| GXPNews - FDA News & Announcements
October 28 - November 1, 2024 |
||
|---|---|---|
 |
 |
 |
 |
 |
| Whats New with CDRH Medical Device News and Events |
||||||||||||||||||
November 1, 2024
October 31, 2024 October 29, 2024
October 28, 2024
October 25, 2024 |
||||||||||||||||||
| CDRH Center for Device and Radiological Health Meetings and Conferences | ||||||||||||||||||
|
||||||||||||||||||
| Whats New with CBER Center for Biologic Evaluation and Research | ||||||||||||||||||
|
||||||||||||||||||
| CBER Meetings and Conferences | ||||||||||||||||||
|
||||||||||||||||||
| Guidance for Biologics | ||||||||||||||||||
|
||||||||||||||||||
 |
||||
Weekly Rules Changes Monday 28 October - 21 CFR Parts 510, 516, 520, 522, 524, 529, 556, and 558 |
||||
| Monday 28 October 2024 | ||||
|
||||
| Tuesday 29 October 2024 | ||||
NONE
|
||||
| Wednesday 30 October 2024 | ||||
|
||||
| Thursday 31 October 2024 | ||||
|
||||
| Friday 1 November 2024 | ||||
|
||||
|
||||
Drug Enforcement Administration (DEA) Food and Drug Administration (FDA) |
||||
Tissue and Cell Key Resources
|
||||
|
||||||
The International GMP
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
 In Vitro Diagnostics Master Handbook - Over 500 Pages including EU Directive 2017/746 |
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
Don't see what you are looking for? Contact John Cuspilich, QA/RA, at jcuspilich@fda.com |
||||||
Drug Approvals:
November 1, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Victoza NDA #022341 |
Liraglutide | Solution; Subcutaneous | Novo Nordisk Inc |
October 31, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Demerol NDA #005010 |
Meperidine Hydrochloride | Injectable; Injection | Quagen |
| Demerol NDA #005010 |
Meperidine Hydrochloride | Syrup; Oral | Quagen |
| Demerol NDA #005010 |
Meperidine Hydrochloride | Tablet; Oral | Quagen |
| Percodan NDA #007337 |
Aspirin; Oxycodone Hydrochloride | Tablet; Oral | Endo Operations |
| Percodan NDA #007337 |
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | Tablet; Oral | Endo Operations |
| Percodan-Demi NDA #007337 |
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | Tablet; Oral | Endo Operations |
| Synalgos-Dc NDA #011483 |
Aspirin; Caffeine; Dihydrocodeine Bitartrate | Capsule; Oral | Sun Pharm Industries |
| Ms Contin NDA #019516 |
Morphine Sulfate | Tablet, Extended Release; Oral | Purdue Pharma Lp |
| Dilaudid NDA #019891 |
Hydromorphone Hydrochloride | Solution; Oral | Rhodes Pharms |
| Dilaudid NDA #019892 |
Hydromorphone Hydrochloride | Tablet; Oral | Rhodes Pharms |
| Fioricet W/ Codeine NDA #020232 |
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Actavis Labs Ut Inc |
| Roxicodone NDA #021011 |
Oxycodone Hydrochloride | Tablet; Oral | Specgx Llc |
| Butrans NDA #021306 |
Buprenorphine | Film, Extended Release; Transdermal | Purdue Pharma Lp |
| Opana Er NDA #021610 |
Oxymorphone Hydrochloride | Tablet, Extended Release; Oral | Endo Operations |
| Oxaliplatin NDA #022160 |
Oxaliplatin | Injectable; Intravenous | Teva Pharms |
| Morphine Sulfate NDA #022195 |
Morphine Sulfate | Solution; Oral | Hikma |
| Morphine Sulfate NDA #022207 |
Morphine Sulfate | Tablet; Oral | Hikma |
| Oxycontin NDA #022272 |
Oxycodone Hydrochloride | Tablet, Extended Release; Oral | Purdue Pharma Lp |
| Nucynta NDA #022304 |
Tapentadol Hydrochloride | Tablet; Oral | Collegium Pharm Inc |
| Conzip NDA #022370 |
Tramadol Hydrochloride | Capsule, Extended Release; Oral | Cipher Pharms Inc |
| Codeine Sulfate NDA #022402 |
Codeine Sulfate | Tablet; Oral | Hikma |
| Methadose ANDA #040050 |
Methadone Hydrochloride | Tablet; Oral | Specgx Llc |
| Oxycodone and Acetaminophen ANDA #040105 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Endo Operations |
| Meperidine Hydrochloride ANDA #040110 |
Meperidine Hydrochloride | Tablet; Oral | Hikma |
| Acetaminophen and Codeine Phosphate ANDA #040119 |
Acetaminophen; Codeine Phosphate | Solution; Oral | Pai Holdings |
| Oxycodone and Acetaminophen ANDA #040171 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Watson Labs |
| Meperidine Hydrochloride ANDA #040186 |
Meperidine Hydrochloride | Tablet; Oral | Watson Labs |
| Meperidine Hydrochloride ANDA #040191 |
Meperidine Hydrochloride | Tablet; Oral | Strides Pharma |
| Oxycodone and Acetaminophen ANDA #040203 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Actavis Elizabeth |
| Methadone Hydrochloride ANDA #040241 |
Methadone Hydrochloride | Tablet; Oral | Vistapharm Llc |
| Oxycodone and Aspirin ANDA #040255 |
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | Tablet; Oral | Ani Pharms |
| Oxycodone and Aspirin ANDA #040260 |
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | Tablet; Oral | Sun Pharm Industries |
| Percocet ANDA #040330 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Endo Operations |
| Meperidine Hydrochloride ANDA #040331 |
Meperidine Hydrochloride | Tablet; Oral | Epic Pharma Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040355 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Strides Pharma |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040400 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Specgx Llc |
| Anexsia 7.5/325 ANDA #040405 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Specgx Llc |
| Anexsia 5/325 ANDA #040409 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Specgx Llc |
| Acetaminophen and Codeine Phosphate ANDA #040419 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Specgx Llc |
| Meperidine Hydrochloride ANDA #040446 |
Meperidine Hydrochloride | Tablet; Oral | Sun Pharm Inds Inc |
| Methadone Hydrochloride ANDA #040517 |
Methadone Hydrochloride | Tablet; Oral | Specgx Llc |
| Oxycodone and Acetaminophen ANDA #040535 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Watson Labs |
| Oxycodone and Acetaminophen ANDA #040545 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Specgx Llc |
| Oxycodone and Acetaminophen ANDA #040608 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Mikart |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040655 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Strides Pharma |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040656 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Strides Pharma |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040736 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Amneal Pharms Ny |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040746 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Amneal Pharms Ny |
| Oxycodone and Acetaminophen ANDA #040777 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Amneal Pharms |
| Oxycodone and Acetaminophen ANDA #040778 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Amneal Pharms Ny |
| Acetaminophen and Codeine Phosphate ANDA #040779 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Amneal Pharms Ny |
| Oxycodone and Acetaminophen ANDA #040800 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Actavis Elizabeth |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040826 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Sun Pharm Inds Ltd |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040834 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Pharm Assoc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040838 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Pharm Assoc |
| Carisoprodol, Aspirin and Codeine Phosphate ANDA #040860 |
Aspirin; Carisoprodol; Codeine Phosphate | Tablet; Oral | Ingenus Pharms Nj |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040881 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Mikart |
| Meperidine Hydrochloride ANDA #040893 |
Meperidine Hydrochloride | Tablet; Oral | Genus |
| Hydrocodone Bitartrate and Acetaminophen ANDA #040894 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Genus |
| Oxycodone and Aspirin ANDA #040910 |
Aspirin; Oxycodone Hydrochloride | Tablet; Oral | Epic Pharma Llc |
| Levorphanol Tartrate ANDA #074278 |
Levorphanol Tartrate | Tablet; Oral | Hikma |
| Hydromorphone Hydrochloride ANDA #074597 |
Hydromorphone Hydrochloride | Tablet; Oral | Hikma |
| Hydromorphone Hydrochloride ANDA #074653 |
Hydromorphone Hydrochloride | Solution; Oral | Hikma |
| Naloxone Hydrochloride and Pentazocine Hydrochloride ANDA #074736 |
Naloxone Hydrochloride; Pentazocine Hydrochloride | Tablet; Oral | Watson Labs |
| Butalbital, Aspirin, Caffeine, and Codeine Phosphate ANDA #074951 |
Aspirin; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Stevens J |
| Butalbital, Aspirin, Caffeine, and Codeine Phosphate ANDA #075231 |
Aspirin; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Lgm Pharma |
| Morphine Sulfate ANDA #075295 |
Morphine Sulfate | Tablet, Extended Release; Oral | Strides Pharma |
| Butorphanol Tartrate ANDA #075499 |
Butorphanol Tartrate | Spray, Metered; Nasal | Apotex |
| Naloxone Hydrochloride and Pentazocine Hydrochloride ANDA #075523 |
Naloxone Hydrochloride; Pentazocine Hydrochloride | Tablet; Oral | Sun Pharm Inds Ltd |
| Naloxone Hydrochloride and Pentazocine Hydrochloride ANDA #075735 |
Naloxone Hydrochloride; Pentazocine Hydrochloride | Tablet; Oral | Lupin |
| Butorphanol Tartrate ANDA #075759 |
Butorphanol Tartrate | Spray, Metered; Nasal | Rising |
| Butorphanol Tartrate ANDA #075824 |
Butorphanol Tartrate | Spray, Metered; Nasal | Hikma |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate ANDA #075929 |
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Nostrum Labs Inc |
| Tramadol Hydrochloride ANDA #075962 |
Tramadol Hydrochloride | Tablet; Oral | Watson Labs |
| Tramadol Hydrochloride ANDA #075964 |
Tramadol Hydrochloride | Tablet; Oral | Sun Pharm Inds Inc |
| Tramadol Hydrochloride ANDA #075968 |
Tramadol Hydrochloride | Tablet; Oral | Graviti Pharms |
| Tramadol Hydrochloride ANDA #075977 |
Tramadol Hydrochloride | Tablet; Oral | Teva |
| Tramadol Hydrochloride ANDA #075981 |
Tramadol Hydrochloride | Tablet; Oral | Apotex |
| Tramadol Hydrochloride ANDA #075982 |
Tramadol Hydrochloride | Tablet; Oral | Pliva |
| Tramadol Hydrochloride ANDA #075983 |
Tramadol Hydrochloride | Tablet; Oral | Specgx Llc |
| Tramadol Hydrochloride ANDA #076003 |
Tramadol Hydrochloride | Tablet; Oral | Amneal Pharms |
| Tramadol Hydrochloride ANDA #076100 |
Tramadol Hydrochloride | Tablet; Oral | Sun Pharm Industries |
| Fentanyl-100 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-12 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-25 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-37 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-50 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-62 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-75 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Fentanyl-87 ANDA #076258 |
Fentanyl | Film, Extended Release; Transdermal | Mylan Technologies |
| Morphine Sulfate ANDA #076412 |
Morphine Sulfate | Tablet, Extended Release; Oral | Specgx Llc |
| Morphine Sulfate ANDA #076438 |
Morphine Sulfate | Tablet, Extended Release; Oral | Specgx Llc |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate ANDA #076560 |
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Lgm Pharma |
| Hydrocodone Bitartrate and Ibuprofen ANDA #076604 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Actavis Labs Fl Inc |
| Oxycodone Hydrochloride ANDA #076636 |
Oxycodone Hydrochloride | Tablet; Oral | Actavis Elizabeth |
| Hydrocodone Bitartrate and Ibuprofen ANDA #076642 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Amneal Pharms Ny |
| Reprexain ANDA #076642 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Amneal Pharms Ny |
| Hydromorphone Hydrochloride ANDA #076723 |
Hydromorphone Hydrochloride | Tablet; Oral | Nostrum Labs Inc |
| Oxycodone Hydrochloride ANDA #076758 |
Oxycodone Hydrochloride | Tablet; Oral | Specgx Llc |
| Hydromorphone Hydrochloride ANDA #076855 |
Hydromorphone Hydrochloride | Tablet; Oral | Specgx Llc |
| Tramadol Hydrochloride and Acetaminophen ANDA #076914 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Graviti Pharms |
| Fentanyl-100 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Fentanyl-12 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Fentanyl-25 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Fentanyl-37 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Fentanyl-50 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Fentanyl-62 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Fentanyl-75 ANDA #077154 |
Fentanyl | Film, Extended Release; Transdermal | Specgx Llc |
| Tramadol Hydrochloride and Acetaminophen ANDA #077184 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Sun Pharm Inds Inc |
| Fentanyl-100 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-12 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-25 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-37 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-50 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-62 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-75 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Fentanyl-87 ANDA #077449 |
Fentanyl | Film, Extended Release; Transdermal | Difgen Pharms |
| Hydrocodone Bitartrate and Ibuprofen ANDA #077454 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Ani Pharms |
| Oxycodone Hydrochloride ANDA #077712 |
Oxycodone Hydrochloride | Tablet; Oral | Strides Pharma |
| Hydrocodone ANDA #077723 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Nostrum Labs Inc |
| Hydrocodone Bitartrate and Ibuprofen ANDA #077723 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Nostrum Labs Inc |
| Tramadol Hydrochloride and Acetaminophen ANDA #077858 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Rising |
| Oxycodone Hydrochloride and Ibuprofen ANDA #078316 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | Barr Labs Inc |
| Morphine Sulfate ANDA #078761 |
Morphine Sulfate | Tablet, Extended Release; Oral | Sun Pharm Inds Ltd |
| Oxycodone Hydrochloride and Ibuprofen ANDA #078769 |
Ibuprofen; Oxycodone Hydrochloride | Tablet; Oral | Actavis Elizabeth |
| Tramadol Hydrochloride and Acetaminophen ANDA #078778 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Nostrum Labs Inc |
| Tramadol Hydrochloride ANDA #078783 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Strides Pharma |
| Morphine Sulfate ANDA #079040 |
Morphine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Oxymorphone Hydrochloride ANDA #079046 |
Oxymorphone Hydrochloride | Tablet, Extended Release; Oral | Actavis Elizabeth |
| Oxymorphone Hydrochloride ANDA #079087 |
Oxymorphone Hydrochloride | Tablet, Extended Release; Oral | Impax Labs |
| Meperidine Hydrochloride ANDA #080448 |
Meperidine Hydrochloride | Tablet; Oral | Sun Pharm Industries |
| Acetaminophen and Codeine Phosphate ANDA #081249 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Fosun Pharma |
| Acetaminophen and Codeine Phosphate ANDA #081250 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Fosun Pharma |
| Percocet ANDA #085106 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Endo Operations |
| Acetaminophen and Codeine Phosphate ANDA #085861 |
Acetaminophen; Codeine Phosphate | Solution; Oral | Actavis Mid Atlantic |
| Acetaminophen and Codeine Phosphate ANDA #085868 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Sun Pharm Inds Ltd |
| Roxicet ANDA #087003 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Hikma |
| Acetaminophen and Codeine Phosphate ANDA #087006 |
Acetaminophen; Codeine Phosphate | Solution; Oral | Wockhardt Bio Ag |
| Acetaminophen and Codeine Phosphate ANDA #087083 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Sun Pharm Inds Ltd |
| Methadone Hydrochloride ANDA #087393 |
Methadone Hydrochloride | Solution; Oral | Hikma |
| Oxycet ANDA #087463 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Specgx Llc |
| Acetaminophen and Codeine Phosphate ANDA #087508 |
Acetaminophen; Codeine Phosphate | Solution; Oral | Genus Lifesciences |
| Oxycodone and Aspirin ANDA #087794 |
Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | Tablet; Oral | Sun Pharm Industries |
| Methadone Hydrochloride ANDA #087997 |
Methadone Hydrochloride | Solution; Oral | Hikma |
| Methadone Hydrochloride ANDA #088108 |
Methadone Hydrochloride | Tablet; Oral | Roxane |
| Methadone Hydrochloride ANDA #088109 |
Methadone Hydrochloride | Tablet; Oral | Roxane |
| Acetaminophen and Codeine Phosphate ANDA #088629 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Nostrum Labs Inc |
| Meperidine Hydrochloride ANDA #088639 |
Meperidine Hydrochloride | Tablet; Oral | Barr |
| Meperidine Hydrochloride ANDA #088640 |
Meperidine Hydrochloride | Tablet; Oral | Barr |
| Meperidine Hydrochloride ANDA #088744 |
Meperidine Hydrochloride | Syrup; Oral | Hikma |
| Roxicet ANDA #089351 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | Hikma |
| Acetaminophen and Codeine Phosphate ANDA #089805 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Strides Pharma |
| Acetaminophen and Codeine Phosphate ANDA #089828 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Strides Pharma |
| Methadone Hydrochloride Intensol ANDA #089897 |
Methadone Hydrochloride | Concentrate; Oral | Hikma |
| Acetaminophen and Codeine Phosphate ANDA #089990 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Strides Pharma |
| Methadone Hydrochloride ANDA #090065 |
Methadone Hydrochloride | Tablet; Oral | Epic Pharma Llc |
| Oxycodone and Aspirin ANDA #090084 |
Aspirin; Oxycodone Hydrochloride | Tablet; Oral | Actavis Labs Fl Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #090118 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Sun Pharm Inds Inc |
| Tramadol Hydrochloride ANDA #090404 |
Tramadol Hydrochloride | Tablet; Oral | Zydus Pharms Usa Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #090415 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Endo Operations |
| Tramadol Hydrochloride and Acetaminophen ANDA #090460 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Zydus Pharms Usa Inc |
| Tramadol Hydrochloride and Acetaminophen ANDA #090485 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Amneal Pharms |
| Oxycodone and Acetaminophen ANDA #090535 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Sun Pharm Inds Inc |
| Methadone Hydrochloride ANDA #090635 |
Methadone Hydrochloride | Tablet; Oral | Thepharmanetwork Llc |
| Oxycodone Hydrochloride ANDA #090659 |
Oxycodone Hydrochloride | Tablet; Oral | Sun Pharm Inds Inc |
| Methadone Hydrochloride ANDA #090707 |
Methadone Hydrochloride | Solution; Oral | Vistapharm Llc |
| Oxycodone and Acetaminophen ANDA #090733 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Endo Operations |
| Oxycodone and Acetaminophen ANDA #090734 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Endo Operations |
| Oxycodone Hydrochloride ANDA #090895 |
Oxycodone Hydrochloride | Tablet; Oral | Epic Pharma Llc |
| Oxymorphone Hydrochloride ANDA #090964 |
Oxymorphone Hydrochloride | Tablet; Oral | Hikma |
| Morphine Sulfate ANDA #091357 |
Morphine Sulfate | Tablet, Extended Release; Oral | Epic Pharma Llc |
| Oxycodone Hydrochloride ANDA #091393 |
Oxycodone Hydrochloride | Tablet; Oral | Avanthi Inc |
| Oxymorphone Hydrochloride ANDA #091443 |
Oxymorphone Hydrochloride | Tablet; Oral | Teva |
| Tramadol Hydrochloride ANDA #091498 |
Tramadol Hydrochloride | Tablet; Oral | Cspc Ouyi Pharm Co |
| Homatropine Methylbromide and Hydrocodone Bitartrate ANDA #091528 |
Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet; Oral | Novel Labs Inc |
| Tramadol Hydrochloride ANDA #091607 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Sun Pharm |
| Tramadol Hydrochloride ANDA #091609 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Actavis Elizabeth |
| Hydrocodone Bitartrate and Ibuprofen ANDA #091633 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Sun Pharm Inds Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #200343 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Genus |
| Morphine Sulfate ANDA #200411 |
Morphine Sulfate | Capsule, Extended Release; Oral | Impax Labs Inc |
| Tramadol Hydrochloride ANDA #200491 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Endo Operations |
| Tramadol Hydrochloride ANDA #200503 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Lupin Ltd |
| Nucynta Er NDA #200533 |
Tapentadol Hydrochloride | Tablet, Extended Release; Oral | Collegium Pharm Inc |
| Oxycodone Hydrochloride NDA #200534 |
Oxycodone Hydrochloride | Capsule; Oral | Genus Lifesciences |
| Oxycodone Hydrochloride NDA #200535 |
Oxycodone Hydrochloride | Solution; Oral | Genus Lifesciences |
| Morphine Sulfate ANDA #200812 |
Morphine Sulfate | Capsule, Extended Release; Oral | Strides Pharma |
| Oxymorphone Hydrochloride ANDA #200822 |
Oxymorphone Hydrochloride | Tablet, Extended Release; Oral | Hikma |
| Morphine Sulfate ANDA #200824 |
Morphine Sulfate | Tablet, Extended Release; Oral | Rising |
| Morphine Sulfate ANDA #201011 |
Morphine Sulfate | Solution; Oral | Nostrum Labs Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #201013 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Aurolife Pharma Llc |
| Oxymorphone Hydrochloride ANDA #201187 |
Oxymorphone Hydrochloride | Tablet; Oral | Epic Pharma Llc |
| Oxycodone Hydrochloride NDA #201194 |
Oxycodone Hydrochloride | Solution; Oral | Vistapharm Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #201295 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Tris Pharma Inc |
| Tramadol Hydrochloride ANDA #201384 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Sun Pharm |
| Oxycodone and Acetaminophen ANDA #201447 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Actavis Elizabeth |
| Oxycodone and Acetaminophen ANDA #201448 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | Nostrum Labs Inc |
| Morphine Sulfate ANDA #201574 |
Morphine Sulfate | Solution; Oral | Padagis Us |
| Tramadol Hydrochloride and Acetaminophen ANDA #201952 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Micro Labs Ltd India |
| Oxycodone and Acetaminophen ANDA #201972 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Aurolife Pharma Llc |
| Tramadol Hydrochloride ANDA #201973 |
Tramadol Hydrochloride | Tablet; Oral | Ipca Labs Ltd |
| Tramadol Hydrochloride ANDA #202075 |
Tramadol Hydrochloride | Tablet; Oral | Strides Pharma |
| Tramadol Hydrochloride and Acetaminophen ANDA #202076 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Alkem Labs Ltd |
| Oxaydo NDA #202080 |
Oxycodone Hydrochloride | Tablet; Oral | Zyla |
| Fentanyl-100 ANDA #202097 |
Fentanyl | Film, Extended Release; Transdermal | Kindeva |
| Fentanyl-12 ANDA #202097 |
Fentanyl | Film, Extended Release; Transdermal | Kindeva |
| Fentanyl-25 ANDA #202097 |
Fentanyl | Film, Extended Release; Transdermal | Kindeva |
| Fentanyl-50 ANDA #202097 |
Fentanyl | Film, Extended Release; Transdermal | Kindeva |
| Fentanyl-75 ANDA #202097 |
Fentanyl | Film, Extended Release; Transdermal | Kindeva |
| Morphine Sulfate ANDA #202104 |
Morphine Sulfate | Capsule, Extended Release; Oral | Upsher Smith Labs |
| Oxycodone Hydrochloride ANDA #202116 |
Oxycodone Hydrochloride | Tablet; Oral | Alvogen |
| Oxycodone and Acetaminophen ANDA #202142 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | Mikart |
| Hydromorphone Hydrochloride ANDA #202144 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | Actavis Labs Fl Inc |
| Oxycodone Hydrochloride ANDA #202160 |
Oxycodone Hydrochloride | Tablet; Oral | Aurolife Pharma Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #202214 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Tris Pharma Inc |
| Codeine Sulfate NDA #202245 |
Codeine Sulfate | Solution; Oral | Hikma |
| Morphine Sulfate ANDA #202348 |
Morphine Sulfate | Solution; Oral | Specgx Llc |
| Oxycodone Hydrochloride ANDA #202537 |
Oxycodone Hydrochloride | Solution; Oral | Vistapharm |
| Oxycodone Hydrochloride ANDA #202662 |
Oxycodone Hydrochloride | Tablet; Oral | Epic Pharma Llc |
| Oxycodone and Acetaminophen ANDA #202677 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Alvogen |
| Morphine Sulfate ANDA #202718 |
Morphine Sulfate | Capsule, Extended Release; Oral | Teva Pharms Usa |
| Oxycodone Hydrochloride ANDA #202773 |
Oxycodone Hydrochloride | Capsule; Oral | Avanthi Inc |
| Acetaminophen and Codeine Phosphate ANDA #202800 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Aurolife Pharma Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #202935 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Strides Pharma |
| Codeine Sulfate ANDA #203046 |
Codeine Sulfate | Tablet; Oral | Lannett Co Inc |
| Morphine Sulfate ANDA #203158 |
Morphine Sulfate | Capsule, Extended Release; Oral | Nortec Dev Assoc |
| Oxycodone Hydrochloride ANDA #203208 |
Oxycodone Hydrochloride | Solution; Oral | Hikma |
| Oxycodone Hydrochloride ANDA #203447 |
Oxycodone Hydrochloride | Solution; Oral | Ani Pharms |
| Tramadol Hydrochloride ANDA #203494 |
Tramadol Hydrochloride | Tablet; Oral | Aurobindo Pharma Ltd |
| Methadone Hydrochloride ANDA #203502 |
Methadone Hydrochloride | Tablet; Oral | Aurolife Pharma Llc |
| Morphine Sulfate ANDA #203518 |
Morphine Sulfate | Solution; Oral | Tris Pharma Inc |
| Hydrocodone Bitartrate and Homatropine Methylbromide ANDA #203535 |
Homatropine Methylbromide; Hydrocodone Bitartrate | Syrup; Oral | Novel Labs Inc |
| Oxycodone Hydrochloride and Acetaminophen ANDA #203573 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | Endo Operations |
| Oxymorphone Hydrochloride ANDA #203601 |
Oxymorphone Hydrochloride | Tablet; Oral | Avanthi Inc |
| Morphine Sulfate ANDA #203602 |
Morphine Sulfate | Tablet, Extended Release; Oral | Novel Labs Inc |
| Oxycodone Hydrochloride ANDA #203638 |
Oxycodone Hydrochloride | Tablet; Oral | Amneal Pharms |
| Nucynta NDA #203794 |
Tapentadol Hydrochloride | Solution; Oral | Collegium Pharm Inc |
| Oxycodone Hydrochloride ANDA #203823 |
Oxycodone Hydrochloride | Capsule; Oral | Lannett Co Inc |
| Morphine Sulfate ANDA #203849 |
Morphine Sulfate | Tablet, Extended Release; Oral | Actavis Elizabeth |
| Hydrocodone Bitartrate and Acetaminophen ANDA #203863 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Epic Pharma Llc |
| Oxycodone Hydrochloride ANDA #204021 |
Oxycodone Hydrochloride | Tablet; Oral | Novel Labs Inc |
| Oxycodone Hydrochloride ANDA #204037 |
Oxycodone Hydrochloride | Solution; Oral | Hikma |
| Methadone Hydrochloride ANDA #204166 |
Methadone Hydrochloride | Tablet; Oral | Vistapharm Llc |
| Hydromorphone Hydrochloride ANDA #204278 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | Padagis Us |
| Oxycodone and Acetaminophen ANDA #204407 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Novel Labs Inc |
| Oxymorphone Hydrochloride ANDA #204459 |
Oxymorphone Hydrochloride | Tablet; Oral | Aurolife Pharma Llc |
| Hydrocodone Bitartrate and Ibuprofen ANDA #204575 |
Hydrocodone Bitartrate; Ibuprofen | Tablet; Oral | Aurolife Pharma Llc |
| Oxycodone Hydrochloride ANDA #204603 |
Oxycodone Hydrochloride | Solution; Oral | Novel Labs Inc |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate ANDA #204649 |
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Strides Pharma |
| Oxycodone Hydrochloride ANDA #204752 |
Oxycodone Hydrochloride | Capsule; Oral | Novel Labs Inc |
| Buprenorphine ANDA #204937 |
Buprenorphine | Film, Extended Release; Transdermal | Watson Labs Teva |
| Oxycodone Hydrochloride ANDA #204979 |
Oxycodone Hydrochloride | Solution; Oral | Ani Pharms |
| Hydrocodone Bitartrate and Acetaminophen ANDA #205001 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Strides Pharma |
| Oxycodone Hydrochloride ANDA #205177 |
Oxycodone Hydrochloride | Capsule; Oral | Ani Pharms |
| Tramadol Hydrochloride ANDA #205257 |
Tramadol Hydrochloride | Tablet, Extended Release; Oral | Mylan |
| Hydrocodone Bitartrate and Aspirin ANDA #205479 |
Aspirin; Hydrocodone Bitartrate | Tablet; Oral | Lgm Pharma |
| Morphine Sulfate ANDA #205509 |
Morphine Sulfate | Solution; Oral | Ani Pharms |
| Hydromorphone Hydrochloride ANDA #205629 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | Osmotica Pharm Us |
| Morphine Sulfate ANDA #205634 |
Morphine Sulfate | Tablet, Extended Release; Oral | Sun Pharm Industries |
| Tramadol Hydrochloride ANDA #205702 |
Tramadol Hydrochloride | Tablet; Oral | Macleods Pharms Ltd |
| Hydromorphone Hydrochloride ANDA #205814 |
Hydromorphone Hydrochloride | Tablet; Oral | Aurolife Pharma Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #206142 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Novel Labs Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #206245 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Novel Labs Inc |
| Oxycodone Hydrochloride ANDA #206456 |
Oxycodone Hydrochloride | Solution; Oral | Xttrium Labs Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #206470 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Actavis Labs Fl Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #206484 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Upsher Smith Labs |
| Morphine Sulfate ANDA #206573 |
Morphine Sulfate | Solution; Oral | Pharm Assoc |
| Hysingla Er NDA #206627 |
Hydrocodone Bitartrate | Tablet, Extended Release; Oral | Purdue Pharma Lp |
| Hydrocodone Bitartrate and Acetaminophen ANDA #206718 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Specgx Llc |
| Oxycodone Hydrochloride ANDA #206822 |
Oxycodone Hydrochloride | Solution; Oral | Pharm Assoc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #206869 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Amneal Pharms Ny |
| Tramadol Hydrochloride and Acetaminophen ANDA #206885 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Macleods Pharms Ltd |
| Oxycodone Hydrochloride ANDA #206914 |
Oxycodone Hydrochloride | Solution; Oral | Pharm Assoc |
| Hydrocodone Bitartrate ANDA #206986 |
Hydrocodone Bitartrate | Capsule, Extended Release; Oral | Alvogen |
| Oxycodone Hydrochloride ANDA #207119 |
Oxycodone Hydrochloride | Tablet; Oral | Nuvo Pharm |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207137 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Amneal Pharms |
| Tramadol Hydrochloride and Acetaminophen ANDA #207152 |
Acetaminophen; Tramadol Hydrochloride | Tablet; Oral | Aurobindo Pharma |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207171 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Lannett Co Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207172 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Lannett Co Inc |
| Oxycodone and Acetaminophen ANDA #207333 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Lannett Co Inc |
| Oxycodone Hydrochloride ANDA #207418 |
Oxycodone Hydrochloride | Tablet; Oral | Ascent Pharms Inc |
| Oxycodone and Acetaminophen ANDA #207419 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Ascent Pharms Inc |
| Buprenorphine ANDA #207490 |
Buprenorphine | Film, Extended Release; Transdermal | Alvogen |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207509 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Wes Pharma Inc |
| Oxycodone and Acetaminophen ANDA #207510 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Wes Pharma Inc |
| Oxycodone Hydrochloride ANDA #207511 |
Oxycodone Hydrochloride | Solution; Oral | Wes Pharma Inc |
| Methadone Hydrochloride ANDA #207537 |
Methadone Hydrochloride | Solution; Oral | Specgx Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #207709 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Aurolife Pharma Llc |
| Belbuca NDA #207932 |
Buprenorphine Hydrochloride | Film; Buccal | Bdsi |
| Xtampza Er NDA #208090 |
Oxycodone | Capsule, Extended Release; Oral | Collegium Pharm Inc |
| Hydrocodone Bitartrate ANDA #208269 |
Hydrocodone Bitartrate | Tablet, Extended Release; Oral | Alvogen |
| Methadone Hydrochloride ANDA #208305 |
Methadone Hydrochloride | Tablet; Oral | Sun Pharm Industries |
| Hydrocodone Bitartrate and Acetaminophen ANDA #208540 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Alvogen |
| Oxycodone Hydrochloride ANDA #208593 |
Oxycodone Hydrochloride | Solution; Oral | Abhai Llc |
| Apadaz NDA #208653 |
Acetaminophen; Benzhydrocodone Hydrochloride | Tablet; Oral | Zevra Therap |
| Tramadol Hydrochloride ANDA #208708 |
Tramadol Hydrochloride | Tablet; Oral | Rubicon |
| Oxycodone Hydrochloride ANDA #208795 |
Oxycodone Hydrochloride | Solution; Oral | Hikma |
| Morphine Sulfate ANDA #208809 |
Morphine Sulfate | Solution; Oral | Hikma |
| Oxycodone Hydrochloride ANDA #208817 |
Oxycodone Hydrochloride | Solution; Oral | Hikma |
| Oxycodone Hydrochloride ANDA #209021 |
Oxycodone Hydrochloride | Solution; Oral | Ascent Pharms Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209036 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Abhai Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209037 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Abhai Llc |
| Oxycodone and Acetaminophen ANDA #209385 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Elite Labs Inc |
| Fentanyl-100 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-12 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-25 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-37 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-50 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-62 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-75 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Fentanyl-87 ANDA #209655 |
Fentanyl | Film, Extended Release; Transdermal | Zydus Pharms |
| Roxybond NDA #209777 |
Oxycodone Hydrochloride | Tablet; Oral | Protega Pharms |
| Oxycodone Hydrochloride ANDA #209897 |
Oxycodone Hydrochloride | Solution; Oral | Wes Pharma Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209924 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Elite Labs Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #209958 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Alvogen |
| Buprenorphine ANDA #210162 |
Buprenorphine | Film, Extended Release; Transdermal | Mylan Tech Viatris |
| Oxymorphone Hydrochloride ANDA #210175 |
Oxymorphone Hydrochloride | Tablet; Oral | Ascent Pharms Inc |
| Hydromorphone Hydrochloride ANDA #210176 |
Hydromorphone Hydrochloride | Solution; Oral | Ascent Pharms Inc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #210211 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Wes Pharma Inc |
| Buprenorphine ANDA #210272 |
Buprenorphine | Film, Extended Release; Transdermal | Difgen Pharms |
| Methadone Hydrochloride ANDA #210484 |
Methadone Hydrochloride | Tablet; Oral | Elite Labs Inc |
| Hydromorphone Hydrochloride ANDA #210506 |
Hydromorphone Hydrochloride | Tablet; Oral | Ascent Pharms Inc |
| Morphine Sulfate ANDA #210610 |
Morphine Sulfate | Tablet; Oral | Upsher Smith Labs |
| Oxycodone and Acetaminophen ANDA #210644 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Abhai Llc |
| Oxycodone Hydrochloride ANDA #210758 |
Oxycodone Hydrochloride | Solution; Oral | Specgx Llc |
| Hydrocodone Bitartrate and Acetaminophen ANDA #211023 |
Acetaminophen; Hydrocodone Bitartrate | Solution; Oral | Wes Pharma Inc |
| Methadone Hydrochloride ANDA #211228 |
Methadone Hydrochloride | Tablet; Oral | Ascent Pharms Inc |
| Levorphanol Tartrate ANDA #211484 |
Levorphanol Tartrate | Tablet; Oral | Virtus |
| Hydrocodone Bitartrate and Acetaminophen ANDA #211487 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Ascent Pharms Inc |
| Oxycodone and Acetaminophen ANDA #211499 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | Abhai Llc |
| Buprenorphine ANDA #211586 |
Buprenorphine | Film, Extended Release; Transdermal | Amneal |
| Buprenorphine Hydrochloride ANDA #211594 |
Buprenorphine Hydrochloride | Film; Buccal | Alvogen |
| Acetaminophen and Codeine Phosphate ANDA #211610 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Wes Pharma Inc |
| Oxycodone and Acetaminophen ANDA #211708 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | Granules |
| Hydrocodone Bitartrate and Acetaminophen ANDA #211729 |
Acetaminophen; Hydrocodone Bitartrate | Tablet; Oral | Granules |
| Oxycodone Hydrochloride ANDA #211748 |
Oxycodone Hydrochloride | Solution; Oral | Alkem Labs Ltd |
| Oxycodone Hydrochloride ANDA #211749 |
Oxycodone Hydrochloride | Solution; Oral | Alkem Labs Ltd |
| Tramadol Hydrochloride ANDA #211825 |
Tramadol Hydrochloride | Tablet; Oral | Unichem |
| Levorphanol Tartrate ANDA #212024 |
Levorphanol Tartrate | Tablet; Oral | Specgx Llc |
| Hydromorphone Hydrochloride ANDA #212133 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | Ascent Pharms Inc |
| Acetaminophen and Codeine Phosphate ANDA #212418 |
Acetaminophen; Codeine Phosphate | Tablet; Oral | Elite Labs Inc |
| Oxycodone Hydrochloride ANDA #212429 |
Oxycodone Hydrochloride | Solution; Oral | Aurolife Pharma Llc |
| Morphine Sulfate ANDA #212451 |
Morphine Sulfate | Tablet; Oral | Alkem Labs Ltd |
| Seglentis NDA #213426 |
Celecoxib; Tramadol Hydrochloride | Tablet; Oral | Kowa Pharms |
| Levorphanol Tartrate ANDA #213479 |
Levorphanol Tartrate | Tablet; Oral | Novitium Pharma |
| Oxycodone Hydrochloride ANDA #213761 |
Oxycodone Hydrochloride | Solution; Oral | Quagen |
| Levorphanol Tartrate ANDA #213906 |
Levorphanol Tartrate | Tablet; Oral | Sun Pharm Inds Inc |
| Qdolo NDA #214044 |
Tramadol Hydrochloride | Solution; Oral | Athena |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate ANDA #215138 |
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Capsule; Oral | Hikma |
| Morphine Sulfate ANDA #215194 |
Morphine Sulfate | Tablet; Oral | Specgx Llc |
| Morphine Sulfate ANDA #215584 |
Morphine Sulfate | Tablet; Oral | Ingenus Pharms Nj |
| Edaravone ANDA #217565 |
Edaravone | Solution; Intravenous | Xgen Pharms |
October 30, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Xylocaine NDA #006488 |
Lidocaine Hydrochloride | Injectable; Injection | Fresenius Kabi Usa |
| Xylocaine W/ Epinephrine NDA #006488 |
Epinephrine; Lidocaine Hydrochloride | Injectable; Injection | Fresenius Kabi Usa |
| Hydromorphone Hydrochloride ANDA #205629 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | Osmotica Pharm Us |
| Hydromorphone Hydrochloride ANDA #205629 |
Hydromorphone Hydrochloride | Tablet, Extended Release; Oral | Osmotica Pharm Us |
| Epinephrine ANDA #215425 |
Epinephrine | Injectable; Injection | Fresenius Kabi Usa |
| Dolutegravir; Lamivudine ANDA #216543 |
Dolutegravir;Lamivudine | Tablet; Oral | Hetero Labs Ltd Iii |
| Ivacaftor ANDA #217086 |
Ivacaftor | Tablet; Oral | Aurobindo Pharma Ltd |
| Cablivi BLA #761112 |
Caplacizumab-Yhdp | Injectable; Injection | Ablynx Nv |
| Briumvi BLA #761238 |
Ublituximab-Xiiy | Injectable; Intravenous | Tg Therapeutics, Inc |
| Briumvi BLA #761238 |
Ublituximab-Xiiy | Injectable; Intravenous | Tg Therapeutics, Inc |
| Loqtorzi BLA #761240 |
Toripalimab-Tpzi | Injectable; Injection | Coherus Biosciences Inc |
October 29, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Haloperidol ANDA #091637 |
Haloperidol Lactate | Injectable; Injection | Sagent Pharms |
| Haloperidol ANDA #200742 |
Haloperidol Lactate | Injectable; Injection | Sagent Pharms |
| Melphalan Hydrochloride ANDA #206523 |
Melphalan Hydrochloride | Injectable; Injection | Avet Lifesciences |
| Ticagrelor ANDA #208541 |
Ticagrelor | Tablet; Oral | Dr Reddys |
| Ticagrelor ANDA #208541 |
Ticagrelor | Tablet; Oral | Dr Reddys |
| Scemblix NDA #215358 |
Asciminib Hydrochloride | Tablet; Oral | Novartis |
| Scemblix NDA #215358 |
Asciminib Hydrochloride | Tablet; Oral | Novartis |
| Cyclophosphamide ANDA #216783 |
Cyclophosphamide | Solution; Intravenous | Nexus |
| Thiamine Hydrochloride ANDA #217181 |
Thiamine Hydrochloride | Injectable; Injection | Steriscience |
| Deflazacort ANDA #217813 |
Deflazacort | Suspension; Oral | Tris Pharma Inc |
| Varenicline Tartrate ANDA #219106 |
Varenicline Tartrate | Tablet; Oral | Indoco |
October 28, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Lysodren NDA #016885 |
Mitotane | Tablet; Oral | Hra Pharma |
| Limbitrol NDA #016949 |
Amitriptyline Hydrochloride; Chlordiazepoxide | Tablet; Oral | Chartwell Rx |
| Limbitrol Ds NDA #016949 |
Amitriptyline Hydrochloride; Chlordiazepoxide | Tablet; Oral | Chartwell Rx |
| Hydralazine Hydrochloride ANDA #040136 |
Hydralazine Hydrochloride | Injectable; Injection | Am Regent |
| Liptruzet NDA #200153 |
Atorvastatin Calcium; Ezetimibe | Tablet; Oral | Organon |
| Liptruzet NDA #200153 |
Atorvastatin Calcium; Ezetimibe | Tablet; Oral | Organon |
| Liptruzet NDA #200153 |
Atorvastatin Calcium; Ezetimibe | Tablet; Oral | Organon |
| Liptruzet NDA #200153 |
Atorvastatin Calcium; Ezetimibe | Tablet; Oral | Organon |
| Abiraterone Acetate ANDA #208339 |
Abiraterone Acetate | Tablet; Oral | Hikma |
| Abiraterone Acetate ANDA #208339 |
Abiraterone Acetate | Tablet; Oral | Hikma |
| Doxycycline Hyclate ANDA #218053 |
Doxycycline Hyclate | Injectable; Injection | Kindos |
| Zinc Sulfate ANDA #218059 |
Zinc Sulfate | Solution; Intravenous | Apotex |
| Nitrofurantoin ANDA #218346 |
Nitrofurantoin | Suspension; Oral | Carnegie |
| Potassium Chloride ANDA #218979 |
Potassium Chloride | Tablet, Extended Release; Oral | Twi Pharms |
October 25, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Sporanox NDA #020083 |
Itraconazole | Capsule; Oral | Janssen Pharms |
| Sporanox NDA #020083 |
Itraconazole | Capsule; Oral | Janssen Pharms |
| Sporanox NDA #020657 |
Itraconazole | Solution; Oral | Janssen Pharms |
| Noxafil NDA #022003 |
Posaconazole | Suspension; Oral | Schering |
| Noxafil NDA #022003 |
Posaconazole | Suspension; Oral | Schering |
| Rosuvastatin Calcium ANDA #079145 |
Rosuvastatin Calcium | Tablet; Oral | Apotex |
| Metronidazole ANDA #090222 |
Metronidazole | Tablet, Extended Release; Oral | Alembic |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Escitalopram Oxalate ANDA #090939 |
Escitalopram Oxalate | Tablet; Oral | Torrent Pharms Ltd |
| Metronidazole ANDA #203458 |
Metronidazole | Tablet; Oral | Unichem |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Dextroamphetamine Sulfate ANDA #203901 |
Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth |
| Metronidazole ANDA #203974 |
Metronidazole | Tablet; Oral | Aurobindo Pharma Ltd |
| Fosaprepitant Dimeglumine ANDA #205020 |
Fosaprepitant Dimeglumine | Powder; Intravenous | Apotex |
| Fosaprepitant Dimeglumine ANDA #205020 |
Fosaprepitant Dimeglumine | Powder; Intravenous | Apotex |
| Noxafil NDA #205053 |
Posaconazole | Tablet, Delayed Release; Oral | Merck Sharp Dohme |
| Noxafil NDA #205053 |
Posaconazole | Tablet, Delayed Release; Oral | Merck Sharp Dohme |
| Metronidazole ANDA #205245 |
Metronidazole | Tablet; Oral | Heritage Pharms Inc |
| Rosuvastatin Calcium ANDA #205587 |
Rosuvastatin Calcium | Tablet; Oral | Lupin |
| Rosuvastatin Calcium ANDA #205587 |
Rosuvastatin Calcium | Tablet; Oral | Lupin |
| Noxafil NDA #205596 |
Posaconazole | Solution; Intravenous | Merck Sharp Dohme |
| Noxafil NDA #205596 |
Posaconazole | Solution; Intravenous | Merck Sharp Dohme |
| Tolsura NDA #208901 |
Itraconazole | Capsule; Oral | Mayne Pharma |
| Tolsura NDA #208901 |
Itraconazole | Capsule; Oral | Mayne Pharma |
| Bupivacaine Hydrochloride ANDA #209087 |
Bupivacaine Hydrochloride | Injectable; Spinal | B Braun Medical Inc |
| Doxycycline Hyclate ANDA #210527 |
Doxycycline Hyclate | Capsule; Oral | Alembic |
| Doxycycline Hyclate ANDA #210527 |
Doxycycline Hyclate | Capsule; Oral | Alembic |
| Neostigmine Methylsulfate ANDA #213244 |
Neostigmine Methylsulfate | Injectable; Injection | Eugia Pharma |
| Neostigmine Methylsulfate ANDA #213244 |
Neostigmine Methylsulfate | Solution; Intravenous | Eugia Pharma |
| Pramipexole Dihydrochloride ANDA #213444 |
Pramipexole Dihydrochloride | Tablet, Extended Release; Oral | Novast Labs |
| Orlynvah NDA #213972 |
Sulopenem Etzadroxil;Probenecid | Tablet | Iterum Therapeutics Us Ltd |
| Noxafil Powdermix Kit NDA #214770 |
Posaconazole | For Suspension, Delayed Release; Oral | Msd Merck Co |
| Noxafil Powdermix Kit NDA #214770 |
Posaconazole | For Suspension, Delayed Release; Oral | Msd Merck Co |
| Octreotide Acetate ANDA #216839 |
Octreotide Acetate | Injectable; Injection | Gland Pharma Ltd |
| Lisdexamfetamine Dimesylate ANDA #217068 |
Lisdexamfetamine Dimesylate | Tablet, Chewable; Oral | Ascent Pharms Inc |
| Lisdexamfetamine Dimesylate ANDA #217068 |
Lisdexamfetamine Dimesylate | Tablet, Chewable; Oral | Ascent Pharms Inc |
| Naproxen ANDA #218497 |
Naproxen | Tablet, Delayed Release; Oral | Novitium Pharma |
| Naproxen ANDA #218497 |
Naproxen | Tablet, Delayed Release; Oral | Novitium Pharma |
| Sarclisa BLA #761113 |
Isatuximab-Irfc | Injectable; Injection | Sanofi Aventis Us |
| Sarclisa BLA #761113 |
Isatuximab-Irfc | Injectable; Injection | Sanofi Aventis Us |
October 24, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Company |
|---|---|---|---|
| Heparin Sodium NDA #000552 |
Heparin Sodium | Injectable; Injection | Aspen Global Inc |
| Liquaemin Lock Flush NDA #000552 |
Heparin Sodium | Injectable; Injection | Aspen Global Inc |
| Liquaemin Sodium NDA #000552 |
Heparin Sodium | Injectable; Injection | Aspen Global Inc |
| Liquaemin Sodium Preservative Free NDA #000552 |
Heparin Sodium | Injectable; Injection | Aspen Global Inc |
| Heparin Lock Flush NDA #017007 |
Heparin Sodium | Injectable; Injection | Hikma |
| Heparin Sodium NDA #017007 |
Heparin Sodium | Injectable; Injection | Hikma |
| Heparin Sodium NDA #017029 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium 20,000 Units In Dextrose 5% NDA #017029 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium 25,000 Units In Dextrose 5% NDA #017029 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% NDA #017029 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium In Plastic Container NDA #017029 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium Preservative Free NDA #017029 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium NDA #017037 |
Heparin Sodium | Injectable; Injection | Hikma |
| Heparin Lock Flush NDA #017064 |
Heparin Sodium | Injectable; Injection | Dr Reddys |
| Heparin Sodium NDA #017064 |
Heparin Sodium | Injectable; Injection | Dr Reddys |
| Heparin Sodium NDA #017651 |
Heparin Sodium | Injectable; Injection | Fresenius Kabi Usa |
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.45% NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.9% NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.9% NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.45% NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.9% NDA #018916 |
Heparin Sodium | Injectable; Injection | Hospira |
| Fragmin NDA #020287 |
Dalteparin Sodium | Injectable; Injection | Pfizer |
| Fragmin NDA #020287 |
Dalteparin Sodium | Injectable; Subcutaneous | Pfizer |
| Flonase Sensimist Allergy Relief NDA #022051 |
Fluticasone Furoate | Spray, Metered; Nasal | Haleon Us Holdings |
| Amantadine Hydrochloride ANDA #075060 |
Amantadine Hydrochloride | Syrup; Oral | Xttrium Labs Inc |
| Amantadine Hydrochloride ANDA #075060 |
Amantadine Hydrochloride | Syrup; Oral | Xttrium Labs Inc |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Fluoxetine Hydrochloride ANDA #076001 |
Fluoxetine Hydrochloride | Capsule; Oral | Teva Pharms Usa |
| Rosuvastatin Calcium ANDA #079161 |
Rosuvastatin Calcium | Tablet; Oral | Strides Pharma |
| Isoniazid ANDA #080936 |
Isoniazid | Tablet; Oral | Barr |
| Isoniazid ANDA #080936 |
Isoniazid | Tablet; Oral | Barr |
| Isoniazid ANDA #080937 |
Isoniazid | Tablet; Oral | Barr |
| Isoniazid ANDA #080937 |
Isoniazid | Tablet; Oral | Barr |
| Heparin Sodium NDA #201370 |
Heparin Sodium | Injectable; Injection | Pfizer |
| Heparin Sodium Preservative Free NDA #201370 |
Heparin Sodium | Injectable; Injection | Pfizer |
| Flonase Allergy Relief NDA #205434 |
Fluticasone Propionate | Spray, Metered; Nasal | Haleon Us Holdings |
| Posaconazole ANDA #208773 |
Posaconazole | Suspension; Oral | Hikma |
| Posaconazole ANDA #208773 |
Posaconazole | Suspension; Oral | Hikma |
| Posaconazole ANDA #208773 |
Posaconazole | Suspension; Oral | Hikma |
| Mesalamine ANDA #214242 |
Mesalamine | Capsule, Extended Release; Oral | Alkem Labs Ltd |
| Minocycline Hydrochloride ANDA #214934 |
Minocycline Hydrochloride | Injectable; Injection | Nexus Pharms |
| Sevelamer Carbonate ANDA #215998 |
Sevelamer Carbonate | Tablet; Oral | Shandong Xinhua |
| Baclofen ANDA #217788 |
Baclofen | Tablet; Oral | Graviti Pharms |
| Baclofen ANDA #217788 |
Baclofen | Tablet; Oral | Graviti Pharms |
| Inmazeb BLA #761169 |
Atoltivimab; Odesivimab; Maftivimab | Solution; Injection | Regeneron Pharmaceuticals |
| Jubbonti BLA #761362 |
Denosumab-Bbdz | Injectable; Subcutaneous | Sandoz Inc |
| Wyost BLA #761362 |
Denosumab-Bbdz | Injectable; Subcutaneous | Sandoz Inc |
|
For technical assistance contact John Cuspilich, RA/QA GMP Publications, For sales & marketing, contact Michael Van Horn.
GMP Publications, Inc. P.O. Box 335, Medford, NJ USA 08055 - 001 (856) 810-7331 - sales@gmppublications.com