GXPNews - FDA News & Announcements October 7 - October 11, 2024
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Whats New with CDER
Drug News and Events

October 11, 2024

October 10, 2024

October 9, 2024

October 8, 2024

October 7, 2024

October 4, 2024
CDER Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
12/10/2024 FDA Clinical Investigator Training Course (CITC) 2024
12/04/2024 December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee
11/21/2024 M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance
11/19/2024 November 19, 2024: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting Announcement
11/15/2024 Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
11/13/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
11/12/2024 Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
11/07/2024 Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
11/07/2024 16th Annual Sentinel Initiative Public Workshop
11/07/2024 Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
11/06/2024 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products
11/04/2024 2024 Scientific Computing and Digital Transformation Symposium
10/31/2024 UPDATED PUBLIC PARTICIPATION INFORMATION: October 31, 2024: Meeting of Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
10/29/2024 October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee
10/28/2024 2024 DIA/FDA Oligonucleotide-Based Therapeutics Conference
10/16/2024 Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub
10/16/2024 Global IDMP Implementation - Getting Closer to the Goal
10/15/2024 FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop
 
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Whats New with CDRH
Medical Device News and Events

October 11, 2024

October 10, 2024

October 8, 2024

October 7, 2024
CDRH Center for Device and Radiological Health Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
12/03/2024 Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)
11/13/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
11/06/2024 FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference
11/06/2024 Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices
10/24/2024 FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)
10/15/2024 Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
 
Whats New with CBER Center for Biologic Evaluation and Research
10/11/2024 SOPP 8402: Designation of Amendments as Major
10/10/2024 October 10, 2024 Approval Letter - COMIRNATY
10/10/2024 CBER Title 21 Vacancy Announcement – Physician (Transfusion Medicine), AD-0602-Band C, Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD)
Closes: November 4, 2024
10/9/2024 2024 Center for Biologics Evaluation and Research (CBER) Science Symposium
Transcripts and recordings available.
10/9/2024 CBER Cures Vacancy Announcement – Office Director, AD-0401-Band G, Office of Therapeutic Products (OTP), Office of Pharmacology/Toxicology (OPT)
Closes: November 8, 2024
10/4/2024 October 3, 2024 Approval Letter - MRESVIA
10/3/2024 CBER Cures Vacancy Announcement - Lead Management Analyst (Data and UFA Tracking Lead), Band C, Office of Management (OM), Division of Human Capital (DHC), Workforce Management Branch (WMB)
Closes: October 17, 2024
CBER Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
11/13/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
10/25/2024 Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants
Guidance for Biologics
 
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Weekly Rules Changes
  • Monday 7 October - NONE
  • Tueday 8 October - NONE
  • Wednesday 9 October - NONE
  • Thursday 10 October - NONE
  • Friday 11 October - NONE
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Tuesday 8 October 2024

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Wednesday 9 October 2024

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Thursday 10 October 2024

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Friday 11 October 2024

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Drug Approvals:

October 10, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Carisoprodol, Aspirin and Codeine Phosphate
ANDA #040860		 Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral Ingenus Pharms Nj
Carisoprodol, Aspirin and Codeine Phosphate
ANDA #040860		 Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral Ingenus Pharms Nj
Rifadin
NDA #050420		 Rifampin Capsule; Oral Sanofi Aventis Us
Rifadin
NDA #050627		 Rifampin Injectable; Injection Sanofi Aventis Us
Rifater
NDA #050705		 Isoniazid; Pyrazinamide; Rifampin Tablet; Oral Sanofi Aventis Us
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Duloxetine Hydrochloride
ANDA #090783		 Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral Teva Pharms Usa
Eylea
BLA #125387		 Aflibercept Injectable; Injection Regeneron Pharmaceuticals
Cabazitaxel
NDA #207949		 Cabazitaxel Solution; Intravenous Accord Hlthcare
Cabazitaxel
NDA #207949		 Cabazitaxel Solution; Intravenous Accord Hlthcare
Durysta
NDA #211911		 Bimatoprost Implant; Ophthalmic Abbvie
Sovuna
NDA #214581		 Hydroxychloroquine Sulfate Tablet; Oral Novitium Pharma
Itovebi
NDA #219249		 Inavolisib Tablet; Oral Genentech Inc
Eylea Hd
BLA #761355		 Aflibercept Injectable; Injection Regeneron Pharmaceuticals
Imuldosa
BLA #761364		 Ustekinumab-Srlf Injectable; Intravenous Accord Biopharma Inc.

October 9, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Propranolol Hydrochloride
ANDA #070979		 Propranolol Hydrochloride Solution; Oral Hikma
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #074951		 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral Stevens J
Carvedilol
ANDA #078786		 Carvedilol Tablet; Oral Mlv
Lanorinal
ANDA #086996		 Aspirin; Butalbital; Caffeine Capsule; Oral Sandoz
Levetiracetam
ANDA #091261		 Levetiracetam Tablet, Extended Release; Oral Apotex Inc
Levetiracetam
ANDA #091261		 Levetiracetam Tablet, Extended Release; Oral Apotex Inc
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Sun Pharm Inds Inc
Hydrocodone Bitartrate and Ibuprofen
ANDA #091633		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Sun Pharm Inds Inc
Lamotrigine
ANDA #200694		 Lamotrigine Tablet; Oral Alkem Labs Ltd
Lamotrigine
ANDA #200694		 Lamotrigine Tablet; Oral Alkem Labs Ltd
Levetiracetam
ANDA #202958		 Levetiracetam Tablet, Extended Release; Oral Apotex
Levetiracetam
ANDA #202958		 Levetiracetam Tablet, Extended Release; Oral Apotex
Cisatracurium Besylate
ANDA #203078		 Cisatracurium Besylate Injectable; Injection Hikma
Cisatracurium Besylate
ANDA #203078		 Cisatracurium Besylate Injectable; Injection Hikma
Xelpros
NDA #206185		 Latanoprost Emulsion; Ophthalmic Sun Pharm
Metaraminol Bitartrate
ANDA #211304		 Metaraminol Bitartrate Injectable; Injection Azurity
Balversa
NDA #212018		 Erdafitinib Tablet; Oral Janssen Biotech
Everolimus
ANDA #212936		 Everolimus Tablet; Oral Mylan
Everolimus
ANDA #212936		 Everolimus Tablet; Oral Mylan
Everolimus
ANDA #212936		 Everolimus Tablet; Oral Mylan
Everolimus
ANDA #212936		 Everolimus Tablet; Oral Mylan
Everolimus
ANDA #212936		 Everolimus Tablet; Oral Mylan
Everolimus
ANDA #212936		 Everolimus Tablet; Oral Mylan
Lacosamide
ANDA #214960		 Lacosamide Solution; Intravenous Somerset Theraps Llc

October 8, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Omnipaque 12
NDA #018956		 Iohexol Solution; Oral Ge Healthcare
Omnipaque 140
NDA #018956		 Iohexol Injectable; Injection Ge Healthcare
Omnipaque 180
NDA #018956		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 210
NDA #018956		 Iohexol Injectable; Injection Ge Healthcare
Omnipaque 240
NDA #018956		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 300
NDA #018956		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 350
NDA #018956		 Iohexol Solution; Injection, Oral Ge Healthcare
Omnipaque 70
NDA #018956		 Iohexol Solution; Urethral Ge Healthcare
Omnipaque 9
NDA #018956		 Iohexol Solution; Oral Ge Healthcare
Omnipaque 240
NDA #020608		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 240
NDA #020608		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 300
NDA #020608		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 300
NDA #020608		 Iohexol Solution; Injection, Oral, Rectal Ge Healthcare
Omnipaque 350
NDA #020608		 Iohexol Solution; Injection, Oral Ge Healthcare
Omnipaque 350
NDA #020608		 Iohexol Solution; Injection, Oral Ge Healthcare
Aveed
NDA #022219		 Testosterone Undecanoate Injectable; Intramuscular Endo Operations
Sulindac
ANDA #072710		 Sulindac Tablet; Oral Epic Pharma
Sulindac
ANDA #072710		 Sulindac Tablet; Oral Epic Pharma
Sulindac
ANDA #072710		 Sulindac Tablet; Oral Epic Pharma
Sulindac
ANDA #072711		 Sulindac Tablet; Oral Epic Pharma
Sulindac
ANDA #072711		 Sulindac Tablet; Oral Epic Pharma
Sulindac
ANDA #072711		 Sulindac Tablet; Oral Epic Pharma
Escitalopram Oxalate
ANDA #078604		 Escitalopram Oxalate Tablet; Oral Invagen Pharms
Escitalopram Oxalate
ANDA #078604		 Escitalopram Oxalate Tablet; Oral Invagen Pharms
Cisatracurium Besylate
ANDA #203079		 Cisatracurium Besylate Injectable; Injection Hikma
Naproxen and Esomeprazole Magnesium
ANDA #204470		 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral Actavis Labs Fl Inc
Naproxen and Esomeprazole Magnesium
ANDA #204470		 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral Actavis Labs Fl Inc
Ibandronate Sodium
ANDA #206887		 Ibandronate Sodium Tablet; Oral Macleods Pharms Ltd
Dimethyl Fumarate
ANDA #210305		 Dimethyl Fumarate Capsule, Delayed Release; Oral Cipla
Hydroxychloroquine Sulfate
ANDA #210441		 Hydroxychloroquine Sulfate Tablet; Oral Appco
Dimethyl Fumarate
ANDA #210499		 Dimethyl Fumarate Capsule, Delayed Release; Oral Accord Hlthcare
Ibuprofen and Famotidine
ANDA #211278		 Famotidine; Ibuprofen Tablet; Oral Teva Pharms Usa
Ibuprofen and Famotidine
ANDA #211278		 Famotidine; Ibuprofen Tablet; Oral Teva Pharms Usa
Ibuprofen and Famotidine
ANDA #211278		 Famotidine; Ibuprofen Tablet; Oral Teva Pharms Usa
Paclitaxel
ANDA #212700		 Paclitaxel Powder; Intravenous Hengrui Pharma
Gemtesa
NDA #213006		 Vibegron Tablet; Oral Urovant
Sugammadex Sodium
ANDA #214337		 Sugammadex Sodium Solution; Intravenous Aspiro
Paliperidone
ANDA #217445		 Paliperidone Tablet, Extended Release; Oral Zydus Pharms

October 7, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Ceftriaxone In Plastic Container
ANDA #065224		 Ceftriaxone Sodium Injectable; Injection Baxter Hlthcare
Citalopram Hydrobromide
ANDA #077232		 Citalopram Hydrobromide Tablet; Oral Heritage Pharma
Citalopram Hydrobromide
ANDA #077232		 Citalopram Hydrobromide Tablet; Oral Heritage Pharma
Citalopram Hydrobromide
ANDA #077654		 Citalopram Hydrobromide Tablet; Oral Glenmark Pharms Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #090432		 Escitalopram Oxalate Tablet; Oral Aurobindo Pharma Ltd
Escitalopram Oxalate
ANDA #202389		 Escitalopram Oxalate Tablet; Oral Accord Hlthcare
Escitalopram Oxalate
ANDA #202389		 Escitalopram Oxalate Tablet; Oral Accord Hlthcare
Escitalopram Oxalate
ANDA #202389		 Escitalopram Oxalate Tablet; Oral Accord Hlthcare
Escitalopram Oxalate
ANDA #202389		 Escitalopram Oxalate Tablet; Oral Accord Hlthcare
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Methylphenidate Hydrochloride
ANDA #203583		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Specgx Llc
Omeprazole and Sodium Bicarbonate
ANDA #205545		 Omeprazole; Sodium Bicarbonate For Suspension; Oral Ajanta Pharma Ltd
Bupropion Hydrochloride
ANDA #207224		 Bupropion Hydrochloride Tablet, Extended Release; Oral Anbison Lab
Bupropion Hydrochloride
ANDA #207224		 Bupropion Hydrochloride Tablet, Extended Release; Oral Anbison Lab
Bupropion Hydrochloride
ANDA #207224		 Bupropion Hydrochloride Tablet, Extended Release; Oral Anbison Lab
Empaveli
NDA #215014		 Pegcetacoplan Solution; Subcutaneous Apellis Pharms
Glycopyrrolate
ANDA #216297		 Glycopyrrolate Solution; Oral Saptalis Pharms

October 4, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Pyridostigmine Bromide
NDA #020414		 Pyridostigmine Bromide Tablet; Oral Us Army
Vesanoid
NDA #020438		 Tretinoin Capsule; Oral Cheplapharm
Cosentyx
BLA #125504		 Secukinumab Injectable; Injection Novartis Pharms Corp
Ameluz
NDA #208081		 Aminolevulinic Acid Hydrochloride Gel; Topical Biofrontera
Esomeprazole Magnesium
ANDA #209647		 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral Amneal Pharms Ny
Esomeprazole Magnesium
ANDA #209647		 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral Amneal Pharms Ny
Jelmyto
NDA #211728		 Mitomycin Powder; Pyelocalyceal Urogen Pharma
Naproxen and Esomeprazole Magnesium
ANDA #213699		 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral Ajanta Pharma Ltd
Everolimus
ANDA #214138		 Everolimus Tablet; Oral Alkem Labs Ltd
Chlorpromazine Hydrochloride
ANDA #216911		 Chlorpromazine Hydrochloride Injectable; Injection Gland Pharma Ltd
Pyridostigmine Bromide
NDA #217604		 Pyridostigmine Bromide Tablet, Extended Release; Oral Amneal Pharms Ny
Rivaroxaban
ANDA #218427		 Rivaroxaban Suspension; Oral Apopharma A Div Of Apotex Inc
Cosentyx
BLA #761349		 Secukinumab Injectable; Injection Novartis Pharms Corp

October 3, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Locoid Lipocream
NDA #020769		 Hydrocortisone Butyrate Cream; Topical Precision Dermat
Butorphanol Tartrate
ANDA #075759		 Butorphanol Tartrate Spray, Metered; Nasal Rising
Hydrocodone Bitartrate and Ibuprofen
ANDA #076604		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Actavis Labs Fl Inc
Hydrocodone Bitartrate and Ibuprofen
ANDA #076604		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Actavis Labs Fl Inc
Hydrocodone Bitartrate and Ibuprofen
ANDA #076642		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Amneal Pharms Ny
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
Reprexain
ANDA #076642		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Amneal Pharms Ny
Hydrocodone
ANDA #077723		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Nostrum Labs Inc
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
Hydrocodone Bitartrate and Ibuprofen
ANDA #077723		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Nostrum Labs Inc
Gabapentin
ANDA #078926		 Gabapentin Tablet; Oral Zydus Pharms Usa Inc
Gabapentin
ANDA #078926		 Gabapentin Tablet; Oral Zydus Pharms Usa Inc
Opdivo
BLA #125554		 Nivolumab Injectable; Injection Bristol Myers Squibb
Milnacipran Hydrochloride
ANDA #205147		 Milnacipran Hydrochloride Tablet; Oral Hetero Labs Ltd V
Hydrocodone Bitartrate and Aspirin
ANDA #205479		 Aspirin; Hydrocodone Bitartrate Tablet; Oral Lgm Pharma
Sugammadex
ANDA #214236		 Sugammadex Injectable; Injection Dr Reddys Labs Ltd
Lifitegrast
ANDA #215058		 Lifitegrast Solution/Drops; Ophthalmic Ingenus Pharms Llc
Methohexital Sodium
ANDA #215488		 Methohexital Sodium Injectable; Injection Steriscience
Sitagliptin
ANDA #216886		 Sitagliptin Tablet; Oral Prinston Pharma Inc
Isoproterenol Hydrochloride
ANDA #217648		 Isoproterenol Hydrochloride Injectable; Injection Gland Pharma Ltd
Chlorothiazide Sodium
ANDA #218630		 Chlorothiazide Sodium Injectable; Injection Gland Pharma Ltd
Cetirizine Hydrochloride
ANDA #218895		 Cetirizine Hydrochloride Tablet; Oral Indoco
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