U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

June 8, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azacitidine
NDA #208216
Azacitidine Powder; Intravenous, Subcutaneous SUPPL-6 Actavis Llc Labeling Approved

June 7, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amoxicillin and Clavulanate Potassium
ANDA #203824
Amoxicillin; Clavulanate Potassium Tablet; Oral SUPPL-13 Hikma Pharms Labeling Approved
Bendamustine Hydrochloride
ANDA #206554
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Nang Kuang Pharm Co Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-26 Barr Labeling Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-27 Barr Labeling Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-26 Barr Labeling Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-27 Barr Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-53 Actavis Elizabeth Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-53 Actavis Elizabeth Labeling Approved
Cyclophosphamide
NDA #210852
Cyclophosphamide Vial; Intravenous ORIG-1 Dr Reddys Labs Ltd Type 5 - New Formulation or New Manufacturer Approved
Darunavir
ANDA #214085
Darunavir Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Dexmedetomidine Hydrochloride
ANDA #217308
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Milla Pharms Approved
Draximage Dtpa
NDA #018511
Technetium Tc-99m Pentetate Kit Injectable; Injection SUPPL-32 Jubilant Labeling Approved
Droxia
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-57 Cheplapharm Labeling Approved
Esomeprazole Magnesium
ANDA #206055
Esomeprazole Magnesium For Suspension, Delayed Release; Oral ORIG-1 Zydus Pharms Approved
Hydrea
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-57 Cheplapharm Labeling Approved
Medroxyprogesterone Acetate
ANDA #215397
Medroxyprogesterone Acetate Injectable; Injection ORIG-1 Amneal Approved
Ticagrelor
ANDA #216187
Ticagrelor Tablet; Oral ORIG-1 Changzhou Pharm Tentative Approval
Veklury
NDA #214787
Remdesivir Powder; Intravenous SUPPL-23 Gilead Sciences Inc Labeling Approved
Veklury
NDA #214787
Remdesivir Solution; Intravenous SUPPL-23 Gilead Sciences Inc Labeling Approved
Vilazodone Hydrochloride
ANDA #208209
Vilazodone Hydrochloride Tablet; Oral SUPPL-1 Accord Hlthcare Labeling Approved
Vilazodone Hydrochloride
ANDA #208209
Vilazodone Hydrochloride Tablet; Oral SUPPL-1 Accord Hlthcare Labeling Approved
Vilazodone Hydrochloride
ANDA #208212
Vilazodone Hydrochloride Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Vilazodone Hydrochloride
ANDA #208212
Vilazodone Hydrochloride Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Vilazodone Hydrochloride
ANDA #208212
Vilazodone Hydrochloride Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved

June 6, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #203434
Acetazolamide Capsule, Extended Release; Oral SUPPL-3 Novast Labs Labeling Approved
Acetazolamide
ANDA #204691
Acetazolamide Capsule, Extended Release; Oral SUPPL-9 Nostrum Labs Inc Labeling Approved
Acetazolamide
ANDA #204691
Acetazolamide Capsule, Extended Release; Oral SUPPL-9 Nostrum Labs Inc Labeling Approved
Alendronate Sodium
ANDA #090124
Alendronate Sodium Tablet; Oral SUPPL-16 Aurobindo Pharma Labeling Approved
Alendronate Sodium
ANDA #090124
Alendronate Sodium Tablet; Oral SUPPL-16 Aurobindo Pharma Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203326
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-30 Hikma Labeling Approved
Cefdinir
ANDA #065332
Cefdinir For Suspension; Oral SUPPL-17 Teva Pharms Labeling Approved
Cefdinir
ANDA #065332
Cefdinir For Suspension; Oral SUPPL-17 Teva Pharms Labeling Approved
Dapsone
ANDA #213907
Dapsone Gel; Topical ORIG-1 Acrux Dds Approved
Enoxaparin Sodium (Preservative Free)
ANDA #214646
Enoxaparin Sodium Injectable; Subcutaneous ORIG-1 Be Pharms Approved
Heparin Sodium
ANDA #214804
Heparin Sodium Injectable; Injection SUPPL-2 Be Pharms Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-15 Senores Pharms Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-15 Senores Pharms Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-15 Senores Pharms Labeling Approved
Ketoconazole
ANDA #210457
Ketoconazole Tablet; Oral SUPPL-2 Strides Pharma Labeling Approved
Ketoconazole
ANDA #210457
Ketoconazole Tablet; Oral SUPPL-2 Strides Pharma Labeling Approved
Mesalamine
ANDA #217533
Mesalamine Capsule, Extended Release; Oral ORIG-1 Amta Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-13 Strides Pharma Labeling Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-14 Strides Pharma Labeling Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-13 Strides Pharma Labeling Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-14 Strides Pharma Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-1 Dr Reddys Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-2 Dr Reddys Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-4 Dr Reddys Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-2 Dr Reddys Labeling Approved
Renvela
NDA #022127
Sevelamer Carbonate Tablet; Oral SUPPL-21 Sanofi Labeling Approved
Renvela
NDA #022127
Sevelamer Carbonate Tablet; Oral SUPPL-21 Sanofi Labeling Approved
Roflumilast
ANDA #208299
Roflumilast Tablet; Oral SUPPL-1 Prinston Inc Labeling Approved
Roflumilast
ANDA #208299
Roflumilast Tablet; Oral SUPPL-1 Prinston Inc Labeling Approved
Roflumilast
ANDA #208299
Roflumilast Tablet; Oral SUPPL-1 Prinston Inc Labeling Approved
Solifenacin Succinate
ANDA #211622
Solifenacin Succinate Tablet; Oral ORIG-1 Lannett Co Inc Approved
Sumatriptan Succinate
ANDA #090358
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-29 Sun Pharm Labeling Approved
Sumatriptan Succinate
ANDA #090358
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-29 Sun Pharm Labeling Approved
Tadalafil
ANDA #212515
Tadalafil Tablet; Oral ORIG-1 Zydus Pharms Approved
Tracleer
NDA #021290
Bosentan Tablet; Oral SUPPL-42 Actelion Labeling Approved
Vancomycin Hydrochloride
ANDA #205694
Vancomycin Hydrochloride Injectable; Injection SUPPL-11 Gland Pharma Ltd Manufacturing (CMC) Approved
Vancomycin Hydrochloride
ANDA #205694
Vancomycin Hydrochloride Injectable; Injection SUPPL-11 Gland Pharma Ltd Manufacturing (CMC) Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-11 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-11 Mylan Labeling Approved

June 5, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bendamustine Hydrochloride
ANDA #204230
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Apotex Approved
Bendamustine Hydrochloride
ANDA #211001
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Kindos Approved
Bendamustine Hydrochloride
ANDA #214739
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Eugia Pharma Approved
Buprenorphine Hydrochloride
ANDA #201760
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-33 Sun Pharm Labeling Approved
Buprenorphine Hydrochloride
ANDA #201760
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-33 Sun Pharm Labeling Approved
Definity
NDA #021064
Perflutren Injectable; Intravenous SUPPL-32 Lantheus Medcl Labeling Approved
Definity Rt
NDA #021064
Perflutren Injectable; Intravenous SUPPL-32 Lantheus Medcl Labeling Approved
Desipramine Hydrochloride
ANDA #208105
Desipramine Hydrochloride Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Desipramine Hydrochloride
ANDA #208105
Desipramine Hydrochloride Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Desipramine Hydrochloride
ANDA #208105
Desipramine Hydrochloride Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container
NDA #020163
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-30 Baxter Hlthcare Labeling Approved
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container
NDA #020163
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-30 Baxter Hlthcare Labeling Approved
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container
NDA #020163
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-30 Baxter Hlthcare Labeling Approved
Foscarnet Sodium
ANDA #213807
Foscarnet Sodium Injectable; Injection ORIG-1 Avet Lifesciences Approved
Oriahnn (Copackaged)
NDA #213388
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium Capsule; Oral SUPPL-3 Abbvie Labeling Approved
Oriahnn (Copackaged)
NDA #213388
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium Capsule; Oral SUPPL-3 Abbvie Labeling Approved
Orilissa
NDA #210450
Elagolix Sodium Tablet; Oral SUPPL-9 Abbvie Labeling Approved
Orilissa
NDA #210450
Elagolix Sodium Tablet; Oral SUPPL-9 Abbvie Labeling Approved
Paclitaxel
ANDA #076131
Paclitaxel Injectable; Injection SUPPL-30 Hospira Manufacturing (CMC) Approved
Prevymis
NDA #209939
Letermovir Tablet; Oral SUPPL-12 Merck Sharp Dohme Efficacy Approved
Prevymis
NDA #209940
Letermovir Solution; Intravenous SUPPL-11 Merck Sharp Dohme Efficacy Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-17 Accord Hlthcare Labeling Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-19 Accord Hlthcare Labeling Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-20 Accord Hlthcare Labeling Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-21 Accord Hlthcare Labeling Approved
Spy Agent Green Kit
NDA #211580
Indocyanine Green Powder; Intravenous, Interstitial SUPPL-6 Novadaq Tech Efficacy Approved
Zoledronic Acid
ANDA #213371
Zoledronic Acid Injectable; Intravenous ORIG-1 Hong Kong Approved

June 2, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adbry
BLA #761180
Tralokinumab Injectable; Injection SUPPL-5 Leo Pharma As Labeling Approved
Anoro Ellipta
NDA #203975
Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-15 Glaxosmithkline Labeling Approved
Buprenorphine Hydrochloride
ANDA #201066
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-22 Mylan Labeling Approved
Buprenorphine Hydrochloride
ANDA #201066
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-22 Mylan Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-30 Sun Pharm Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-30 Sun Pharm Labeling Approved
Ciprofloxacin Hydrochloride
ANDA #077689
Ciprofloxacin Hydrochloride Solution/Drops; Ophthalmic SUPPL-2 Rising Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #207630
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-1 Eugia Pharma Manufacturing (CMC) Approved
Eplerenone
ANDA #213812
Eplerenone Tablet; Oral ORIG-1 Annora Pharma Approved
Lampit
NDA #213464
Nifurtimox Tablet; Oral SUPPL-5 Bayer Healthcare Efficacy Approved
Larin 1/20
ANDA #202995
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 SUPPL-2 Novast Labs Labeling Approved
Larin 1/20
ANDA #202995
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 SUPPL-9 Novast Labs Labeling Approved
Larin 1/20
ANDA #202995
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 SUPPL-10 Novast Labs Labeling Approved
Minocycline
ANDA #214934
Minocycline Vial; Single-Use ORIG-1 Nexus Pharms Tentative Approval
Nadolol
ANDA #211763
Nadolol Tablet; Oral ORIG-1 Alembic Approved
Naloxone Hydrochloride
ANDA #213279
Naloxone Hydrochloride Injectable; Injection SUPPL-3 Eugia Pharma Labeling Approved
Naloxone Hydrochloride
ANDA #213279
Naloxone Hydrochloride Injectable; Injection SUPPL-5 Eugia Pharma Labeling Approved
Nelarabine
ANDA #215057
Nelarabine Injectable; Intravenous ORIG-1 Nexus Pharms Approved
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral SUPPL-6 Par Pharm Inc Labeling Approved
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral SUPPL-6 Par Pharm Inc Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-28 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-30 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-32 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-42 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-28 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-30 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-32 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-42 Dr Reddys Labs Ltd Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-6 Aurobindo Pharma Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-7 Aurobindo Pharma Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Rifaximin
ANDA #214369
Rifaximin Tablet; Oral ORIG-1 Norwich Pharmaceuticals Inc Tentative Approval
Tacrolimus
ANDA #200744
Tacrolimus Ointment; Topical SUPPL-11 Fougera Pharms Inc Labeling Approved
Ticagrelor
ANDA #217328
Ticagrelor Tablet; Oral ORIG-1 Annora Pharma Tentative Approval
Trelegy Ellipta
NDA #209482
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-18 Glaxosmithkline Labeling Approved

June 1, 2023

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Arikayce Kit
NDA #207356
Amikacin Sulfate Suspension, Liposomal; Inhalation SUPPL-13 Insmed Inc Labeling Approved
Arikayce Kit
NDA #207356
Amikacin Sulfate Suspension, Liposomal; Inhalation SUPPL-13 Insmed Inc Labeling Approved
Bendamustine Hydrochloride
ANDA #214576
Bendamustine Hydrochloride Injectable; Injection ORIG-1 Eugia Pharma Speclts Tentative Approval
Dicyclomine Hydrochloride
ANDA #216782
Dicyclomine Hydrochloride Tablet; Oral ORIG-1 Twi Pharms Approved
Mycophenolate Mofetil Hydrochloride
ANDA #214283
Mycophenolate Mofetil Hydrochloride Injectable; Injection ORIG-1 Bpi Labs Approved
Olmesartan Medoxomil and Hydrochlorothiazide
ANDA #204801
Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Pregabalin
ANDA #214496
Pregabalin Tablet, Extended Release; Oral ORIG-1 Sinotherapeutics Inc Approved

June 8, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azacitidine
NDA #208216
Azacitidine Powder; Intravenous, Subcutaneous SUPPL-6 Actavis Llc Labeling Approved

June 7, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amoxicillin and Clavulanate Potassium
ANDA #203824
Amoxicillin; Clavulanate Potassium Tablet; Oral SUPPL-13 Hikma Pharms Labeling Approved
Bendamustine Hydrochloride
ANDA #206554
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Nang Kuang Pharm Co Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-26 Barr Labeling Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-27 Barr Labeling Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-26 Barr Labeling Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-27 Barr Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-53 Actavis Elizabeth Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #091422
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-53 Actavis Elizabeth Labeling Approved
Cyclophosphamide
NDA #210852
Cyclophosphamide Vial; Intravenous ORIG-1 Dr Reddys Labs Ltd Type 5 - New Formulation or New Manufacturer Approved
Darunavir
ANDA #214085
Darunavir Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Tentative Approval
Dexmedetomidine Hydrochloride
ANDA #217308
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Milla Pharms Approved
Draximage Dtpa
NDA #018511
Technetium Tc-99m Pentetate Kit Injectable; Injection SUPPL-32 Jubilant Labeling Approved
Droxia
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-57 Cheplapharm Labeling Approved
Esomeprazole Magnesium
ANDA #206055
Esomeprazole Magnesium For Suspension, Delayed Release; Oral ORIG-1 Zydus Pharms Approved
Hydrea
NDA #016295
Hydroxyurea Capsule; Oral SUPPL-57 Cheplapharm Labeling Approved
Medroxyprogesterone Acetate
ANDA #215397
Medroxyprogesterone Acetate Injectable; Injection ORIG-1 Amneal Approved
Ticagrelor
ANDA #216187
Ticagrelor Tablet; Oral ORIG-1 Changzhou Pharm Tentative Approval
Veklury
NDA #214787
Remdesivir Powder; Intravenous SUPPL-23 Gilead Sciences Inc Labeling Approved
Veklury
NDA #214787
Remdesivir Solution; Intravenous SUPPL-23 Gilead Sciences Inc Labeling Approved
Vilazodone Hydrochloride
ANDA #208209
Vilazodone Hydrochloride Tablet; Oral SUPPL-1 Accord Hlthcare Labeling Approved
Vilazodone Hydrochloride
ANDA #208209
Vilazodone Hydrochloride Tablet; Oral SUPPL-1 Accord Hlthcare Labeling Approved
Vilazodone Hydrochloride
ANDA #208212
Vilazodone Hydrochloride Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Vilazodone Hydrochloride
ANDA #208212
Vilazodone Hydrochloride Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Vilazodone Hydrochloride
ANDA #208212
Vilazodone Hydrochloride Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved

June 6, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #203434
Acetazolamide Capsule, Extended Release; Oral SUPPL-3 Novast Labs Labeling Approved
Acetazolamide
ANDA #204691
Acetazolamide Capsule, Extended Release; Oral SUPPL-9 Nostrum Labs Inc Labeling Approved
Acetazolamide
ANDA #204691
Acetazolamide Capsule, Extended Release; Oral SUPPL-9 Nostrum Labs Inc Labeling Approved
Alendronate Sodium
ANDA #090124
Alendronate Sodium Tablet; Oral SUPPL-16 Aurobindo Pharma Labeling Approved
Alendronate Sodium
ANDA #090124
Alendronate Sodium Tablet; Oral SUPPL-16 Aurobindo Pharma Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #203326
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-30 Hikma Labeling Approved
Cefdinir
ANDA #065332
Cefdinir For Suspension; Oral SUPPL-17 Teva Pharms Labeling Approved
Cefdinir
ANDA #065332
Cefdinir For Suspension; Oral SUPPL-17 Teva Pharms Labeling Approved
Dapsone
ANDA #213907
Dapsone Gel; Topical ORIG-1 Acrux Dds Approved
Enoxaparin Sodium (Preservative Free)
ANDA #214646
Enoxaparin Sodium Injectable; Subcutaneous ORIG-1 Be Pharms Approved
Heparin Sodium
ANDA #214804
Heparin Sodium Injectable; Injection SUPPL-2 Be Pharms Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-15 Senores Pharms Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-15 Senores Pharms Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-15 Senores Pharms Labeling Approved
Ketoconazole
ANDA #210457
Ketoconazole Tablet; Oral SUPPL-2 Strides Pharma Labeling Approved
Ketoconazole
ANDA #210457
Ketoconazole Tablet; Oral SUPPL-2 Strides Pharma Labeling Approved
Mesalamine
ANDA #217533
Mesalamine Capsule, Extended Release; Oral ORIG-1 Amta Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-13 Strides Pharma Labeling Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-14 Strides Pharma Labeling Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-13 Strides Pharma Labeling Approved
Mycophenolate Mofetil
ANDA #090111
Mycophenolate Mofetil Capsule; Oral SUPPL-14 Strides Pharma Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-1 Dr Reddys Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-2 Dr Reddys Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-4 Dr Reddys Labeling Approved
Nitroglycerin
ANDA #208191
Nitroglycerin Tablet; Sublingual SUPPL-2 Dr Reddys Labeling Approved
Renvela
NDA #022127
Sevelamer Carbonate Tablet; Oral SUPPL-21 Sanofi Labeling Approved
Renvela
NDA #022127
Sevelamer Carbonate Tablet; Oral SUPPL-21 Sanofi Labeling Approved
Roflumilast
ANDA #208299
Roflumilast Tablet; Oral SUPPL-1 Prinston Inc Labeling Approved
Roflumilast
ANDA #208299
Roflumilast Tablet; Oral SUPPL-1 Prinston Inc Labeling Approved
Roflumilast
ANDA #208299
Roflumilast Tablet; Oral SUPPL-1 Prinston Inc Labeling Approved
Solifenacin Succinate
ANDA #211622
Solifenacin Succinate Tablet; Oral ORIG-1 Lannett Co Inc Approved
Sumatriptan Succinate
ANDA #090358
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-29 Sun Pharm Labeling Approved
Sumatriptan Succinate
ANDA #090358
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-29 Sun Pharm Labeling Approved
Tadalafil
ANDA #212515
Tadalafil Tablet; Oral ORIG-1 Zydus Pharms Approved
Tracleer
NDA #021290
Bosentan Tablet; Oral SUPPL-42 Actelion Labeling Approved
Vancomycin Hydrochloride
ANDA #205694
Vancomycin Hydrochloride Injectable; Injection SUPPL-11 Gland Pharma Ltd Manufacturing (CMC) Approved
Vancomycin Hydrochloride
ANDA #205694
Vancomycin Hydrochloride Injectable; Injection SUPPL-11 Gland Pharma Ltd Manufacturing (CMC) Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-11 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-7 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Venlafaxine Hydrochloride
ANDA #078789
Venlafaxine Hydrochloride Capsule, Extended Release; Oral SUPPL-11 Mylan Labeling Approved

June 5, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bendamustine Hydrochloride
ANDA #204230
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Apotex Approved
Bendamustine Hydrochloride
ANDA #211001
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Kindos Approved
Bendamustine Hydrochloride
ANDA #214739
Bendamustine Hydrochloride Powder; Iv (Infusion) ORIG-1 Eugia Pharma Approved
Buprenorphine Hydrochloride
ANDA #201760
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-33 Sun Pharm Labeling Approved
Buprenorphine Hydrochloride
ANDA #201760
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-33 Sun Pharm Labeling Approved
Definity
NDA #021064
Perflutren Injectable; Intravenous SUPPL-32 Lantheus Medcl Labeling Approved
Definity Rt
NDA #021064
Perflutren Injectable; Intravenous SUPPL-32 Lantheus Medcl Labeling Approved
Desipramine Hydrochloride
ANDA #208105
Desipramine Hydrochloride Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Desipramine Hydrochloride
ANDA #208105
Desipramine Hydrochloride Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Desipramine Hydrochloride
ANDA #208105
Desipramine Hydrochloride Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container
NDA #020183
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-29 Baxter Hlthcare Labeling Approved
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container
NDA #020163
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-30 Baxter Hlthcare Labeling Approved
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container
NDA #020163
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-30 Baxter Hlthcare Labeling Approved
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container
NDA #020163
Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Solution; Intraperitoneal SUPPL-30 Baxter Hlthcare Labeling Approved
Foscarnet Sodium
ANDA #213807
Foscarnet Sodium Injectable; Injection ORIG-1 Avet Lifesciences Approved
Oriahnn (Copackaged)
NDA #213388
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium Capsule; Oral SUPPL-3 Abbvie Labeling Approved
Oriahnn (Copackaged)
NDA #213388
Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium Capsule; Oral SUPPL-3 Abbvie Labeling Approved
Orilissa
NDA #210450
Elagolix Sodium Tablet; Oral SUPPL-9 Abbvie Labeling Approved
Orilissa
NDA #210450
Elagolix Sodium Tablet; Oral SUPPL-9 Abbvie Labeling Approved
Paclitaxel
ANDA #076131
Paclitaxel Injectable; Injection SUPPL-30 Hospira Manufacturing (CMC) Approved
Prevymis
NDA #209939
Letermovir Tablet; Oral SUPPL-12 Merck Sharp Dohme Efficacy Approved
Prevymis
NDA #209940
Letermovir Solution; Intravenous SUPPL-11 Merck Sharp Dohme Efficacy Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-17 Accord Hlthcare Labeling Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-19 Accord Hlthcare Labeling Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-20 Accord Hlthcare Labeling Approved
Quetiapine Fumarate
ANDA #202152
Quetiapine Fumarate Tablet; Oral SUPPL-21 Accord Hlthcare Labeling Approved
Spy Agent Green Kit
NDA #211580
Indocyanine Green Powder; Intravenous, Interstitial SUPPL-6 Novadaq Tech Efficacy Approved
Zoledronic Acid
ANDA #213371
Zoledronic Acid Injectable; Intravenous ORIG-1 Hong Kong Approved

June 2, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adbry
BLA #761180
Tralokinumab Injectable; Injection SUPPL-5 Leo Pharma As Labeling Approved
Anoro Ellipta
NDA #203975
Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-15 Glaxosmithkline Labeling Approved
Buprenorphine Hydrochloride
ANDA #201066
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-22 Mylan Labeling Approved
Buprenorphine Hydrochloride
ANDA #201066
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-22 Mylan Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-30 Sun Pharm Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-30 Sun Pharm Labeling Approved
Ciprofloxacin Hydrochloride
ANDA #077689
Ciprofloxacin Hydrochloride Solution/Drops; Ophthalmic SUPPL-2 Rising Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #207630
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-1 Eugia Pharma Manufacturing (CMC) Approved
Eplerenone
ANDA #213812
Eplerenone Tablet; Oral ORIG-1 Annora Pharma Approved
Lampit
NDA #213464
Nifurtimox Tablet; Oral SUPPL-5 Bayer Healthcare Efficacy Approved
Larin 1/20
ANDA #202995
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 SUPPL-2 Novast Labs Labeling Approved
Larin 1/20
ANDA #202995
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 SUPPL-9 Novast Labs Labeling Approved
Larin 1/20
ANDA #202995
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-21 SUPPL-10 Novast Labs Labeling Approved
Minocycline
ANDA #214934
Minocycline Vial; Single-Use ORIG-1 Nexus Pharms Tentative Approval
Nadolol
ANDA #211763
Nadolol Tablet; Oral ORIG-1 Alembic Approved
Naloxone Hydrochloride
ANDA #213279
Naloxone Hydrochloride Injectable; Injection SUPPL-3 Eugia Pharma Labeling Approved
Naloxone Hydrochloride
ANDA #213279
Naloxone Hydrochloride Injectable; Injection SUPPL-5 Eugia Pharma Labeling Approved
Nelarabine
ANDA #215057
Nelarabine Injectable; Intravenous ORIG-1 Nexus Pharms Approved
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral SUPPL-6 Par Pharm Inc Labeling Approved
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
ANDA #206137
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral SUPPL-6 Par Pharm Inc Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-28 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-30 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-32 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-42 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-28 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-30 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-32 Dr Reddys Labs Ltd Labeling Approved
Omeprazole Magnesium
ANDA #078878
Omeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-42 Dr Reddys Labs Ltd Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-6 Aurobindo Pharma Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-7 Aurobindo Pharma Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-16 Alkem Labs Ltd Labeling Approved
Rifaximin
ANDA #214369
Rifaximin Tablet; Oral ORIG-1 Norwich Pharmaceuticals Inc Tentative Approval
Tacrolimus
ANDA #200744
Tacrolimus Ointment; Topical SUPPL-11 Fougera Pharms Inc Labeling Approved
Ticagrelor
ANDA #217328
Ticagrelor Tablet; Oral ORIG-1 Annora Pharma Tentative Approval
Trelegy Ellipta
NDA #209482
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-18 Glaxosmithkline Labeling Approved

June 1, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Arikayce Kit
NDA #207356
Amikacin Sulfate Suspension, Liposomal; Inhalation SUPPL-13 Insmed Inc Labeling Approved
Arikayce Kit
NDA #207356
Amikacin Sulfate Suspension, Liposomal; Inhalation SUPPL-13 Insmed Inc Labeling Approved
Bendamustine Hydrochloride
ANDA #214576
Bendamustine Hydrochloride Injectable; Injection ORIG-1 Eugia Pharma Speclts Tentative Approval
Dicyclomine Hydrochloride
ANDA #216782
Dicyclomine Hydrochloride Tablet; Oral ORIG-1 Twi Pharms Approved
Mycophenolate Mofetil Hydrochloride
ANDA #214283
Mycophenolate Mofetil Hydrochloride Injectable; Injection ORIG-1 Bpi Labs Approved
Olmesartan Medoxomil and Hydrochlorothiazide
ANDA #204801
Hydrochlorothiazide; Olmesartan Medoxomil Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Pregabalin
ANDA #214496
Pregabalin Tablet, Extended Release; Oral ORIG-1 Sinotherapeutics Inc Approved

May 31, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bupropion Hydrochloride
ANDA #216800
Bupropion Hydrochloride Tablet, Extended Release; Oral ORIG-1 Annora Pharma Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-13 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-20 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-2 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-5 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-9 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-13 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-18 Hec Pharm Labeling Approved
Clarithromycin
ANDA #203584
Clarithromycin Tablet; Oral SUPPL-20 Hec Pharm Labeling Approved
Claritin
NDA #021952
Loratadine Capsule; Oral SUPPL-22 Bayer Healthcare Llc Labeling Approved
Cotellic
NDA #206192
Cobimetinib Fumarate Tablet; Oral SUPPL-6 Genentech Inc Labeling Approved
Dapsone
ANDA #212701
Dapsone Gel; Topical ORIG-1 Amneal Approved
Gefitinib
ANDA #212827
Gefitinib Tablet; Oral ORIG-1 Natco Approved
Injectafer
NDA #203565
Ferric Carboxymaltose Solution; Intravenous SUPPL-20 Am Regent Efficacy Approved
Injectafer
NDA #203565
Ferric Carboxymaltose Solution; Intravenous SUPPL-24 Am Regent Labeling Approved
Lynparza
NDA #208558
Olaparib Tablet; Oral SUPPL-25 Astrazeneca Efficacy Approved
Naloxone Hydrochloride
ANDA #070172
Naloxone Hydrochloride Injectable; Injection SUPPL-31 Hospira Labeling Approved
Naproxen
ANDA #216908
Naproxen Tablet, Delayed Release; Oral ORIG-1 Tulex Pharms Inc Approved
Pirfenidone
ANDA #212709
Pirfenidone Tablet; Oral ORIG-1 Apotex Approved
Pramipexole Dihydrochloride
ANDA #203615
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-3 Actavis Elizabeth Labeling Approved
Pramipexole Dihydrochloride
ANDA #203615
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-3 Actavis Elizabeth Labeling Approved
Pramipexole Dihydrochloride
ANDA #204518
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-6 Alembic Labeling Approved
Pramipexole Dihydrochloride
ANDA #204518
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-6 Alembic Labeling Approved
Pramipexole Dihydrochloride
ANDA #204518
Pramipexole Dihydrochloride Tablet, Extended Release; Oral SUPPL-6 Alembic Labeling Approved

May 30, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cisatracurium Besylate
ANDA #212190
Cisatracurium Besylate Injectable; Injection SUPPL-2 Piramal Hlthcare Uk Labeling Approved
Cisatracurium Besylate
ANDA #212190
Cisatracurium Besylate Injectable; Injection SUPPL-4 Piramal Hlthcare Uk Labeling Approved
Cisatracurium Besylate
ANDA #212432
Cisatracurium Besylate Injectable; Injection SUPPL-1 Piramal Hlthcare Uk Labeling Approved
Cisatracurium Besylate
ANDA #212432
Cisatracurium Besylate Injectable; Injection SUPPL-3 Piramal Hlthcare Uk Labeling Approved
Fintepla
NDA #212102
Fenfluramine Hydrochloride Solution; Oral SUPPL-9 Zogenix Inc REMS Approved
Jencycla
ANDA #091323
Norethindrone Tablet; Oral-28 SUPPL-8 Lupin Ltd Labeling Approved
Lisdexamfetamine Dimesylate
ANDA #217442
Lisdexamfetamine Dimesylate Capsule; Oral ORIG-1 Ascent Pharms Inc Tentative Approval
Mesalamine
ANDA #216941
Mesalamine Enema; Rectal ORIG-1 Encube Approved
Obeticholic Acid
ANDA #214862
Obeticholic Acid Tablet; Oral ORIG-1 Apotex Approved
Obeticholic Acid
ANDA #214980
Obeticholic Acid Tablet; Oral ORIG-1 Lupin Ltd Approved
Obeticholic Acid
ANDA #215017
Obeticholic Acid Tablet; Oral ORIG-1 Msn Approved
Quetiapine Fumarate
ANDA #202674
Quetiapine Fumarate Tablet; Oral SUPPL-22 Unichem Labeling Approved
Quetiapine Fumarate
ANDA #202674
Quetiapine Fumarate Tablet; Oral SUPPL-22 Unichem Labeling Approved
Semglee
BLA #761201
Insulin Glargine-Yfgn Injectable; Injection SUPPL-7 Mylan Pharms Inc Labeling Approved
Semglee
BLA #761201
Insulin Glargine-Yfgn Injectable; Injection SUPPL-7 Mylan Pharms Inc Labeling Approved
Semglee
BLA #761201
Insulin Glargine-Yfgn Injectable; Injection SUPPL-7 Mylan Pharms Inc Labeling Approved
Vevye
NDA #217469
Cyclosporine Solution; Ophthalmic ORIG-1 Novaliq Gmbh Type 5 - New Formulation or New Manufacturer Approved

May 28, 2023

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #207857
Albuterol Sulfate Solution; Inhalation SUPPL-8 Sun Pharm Labeling Approved
Albuterol Sulfate
ANDA #207857
Albuterol Sulfate Solution; Inhalation SUPPL-8 Sun Pharm Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-30 Pliva Labeling Approved
Azithromycin
ANDA #065246
Azithromycin For Suspension; Oral SUPPL-30 Pliva Labeling Approved
Back to Top