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.

July 7, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cervidil
NDA #020411
Dinoprostone Insert, Extended Release; Vaginal SUPPL-31 Ferring Pharms Inc Labeling Approved
Exondys 51
NDA #206488
Eteplirsen Solution; Intravenous SUPPL-19 Sarepta Theraps Inc Labeling Approved
Inqovi
NDA #212576
Decitabine;Cedazuridine Tablet; Oral ORIG-1 Astex Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Vibativ
NDA #022110
Telavancin Hydrochloride Powder; Intravenous SUPPL-16 Cumberland Pharms Labeling Approved

July 6, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cyclobenzaprine Hydrochloride
ANDA #213324
Cyclobenzaprine Hydrochloride Tablet; Oral ORIG-1 Unichem Labs Ltd Approved
Cyramza
BLA #125477
Ramucirumab Injectable; Injection SUPPL-37 Eli Lilly and Co Labeling Approved
Dalfampridine
ANDA #206858
Dalfampridine Tablet, Extended Release; Oral ORIG-1 Mylan Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-25 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-25 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-23 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-23 Dr Reddys Labs Ltd Labeling Approved
Doxylamine Succinate and Pyridoxine Hydrochloride
ANDA #207825
Doxylamine Succinate; Pyridoxine Hydrochloride Tablet, Delayed Release; Oral ORIG-1 Mylan Pharms Inc Approved
Enalapril Maleate and Hydrochlorothiazide
ANDA #076486
Enalapril Maleate; Hydrochlorothiazide Tablet; Oral SUPPL-16 Nostrum Labs Inc Labeling Approved
Erythromycin
ANDA #212015
Erythromycin Tablet; Oral ORIG-1 Torrent Approved
Hulio
BLA #761154
Adalimumab-Fkjp Injectable; Injection ORIG-1 Mylan Pharms Inc Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-5 Novartis Efficacy Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet, Tablet; Oral SUPPL-8 Novartis Efficacy Approved
Levetiracetam In Sodium Chloride
ANDA #213532
Levetiracetam Injectable; Intravenous ORIG-1 Nexus Pharms Approved
Qwo
BLA #761146
Collagenase Clostridium Histolyticum-Aaes Injectable; Injection ORIG-1 Endo Global Aesthetics Ltd Approved
Rifampin
ANDA #206736
Rifampin Injectable; Injection SUPPL-1 Watson Pharms Teva Labeling Approved
Rifampin
ANDA #206736
Rifampin Injectable; Injection SUPPL-2 Watson Pharms Teva Labeling Approved
Rifampin
ANDA #206736
Rifampin Injectable; Injection SUPPL-3 Watson Pharms Teva Labeling Approved
Verapamil Hydrochloride
ANDA #212965
Verapamil Hydrochloride Injectable; Injection ORIG-1 Aurobindo Pharma Ltd Approved

July 2, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bendamustine Hydrochloride
NDA #212209
Bendamustine Hydrochloride Injectable; Injection ORIG-1 Slayback Pharma Llc Type 5 - New Formulation or New Manufacturer Tentative Approval
Byfavo
NDA #212295
Remimazolam Injectable; Injection ORIG-1 Cosmo Technologies Ltd Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Deferasirox
ANDA #210555
Deferasirox Tablet; Oral ORIG-2 Alkem Labs Ltd Approved
Erlotinib Hydrochloride
ANDA #211083
Erlotinib Hydrochloride Tablet; Oral ORIG-1 Accord Hlthcare Approved
Fingolimod Hydrochloride
ANDA #208008
Fingolimod Hydrochloride Capsule; Oral ORIG-1 Teva Pharms Usa Approved
Heparin Sodium
NDA #017029
Heparin Sodium Injectable; Injection SUPPL-156 Fresenius Kabi Usa Labeling Approved
Heparin Sodium
NDA #017651
Heparin Sodium Injectable; Injection SUPPL-66 Fresenius Kabi Usa Labeling Approved
Heparin Sodium In Plastic Container
NDA #017029
Heparin Sodium Injectable; Injection SUPPL-156 Fresenius Kabi Usa Labeling Approved
Heparin Sodium Preservative Free
NDA #017029
Heparin Sodium Injectable; Injection SUPPL-156 Fresenius Kabi Usa Labeling Approved
Methocarbamol
ANDA #040489
Methocarbamol Tablet; Oral SUPPL-15 Oxford Pharms Labeling Approved
Methocarbamol
ANDA #040489
Methocarbamol Tablet; Oral SUPPL-15 Oxford Pharms Labeling Approved
Methocarbamol
ANDA #203550
Methocarbamol Tablet; Oral SUPPL-2 Dbl Pharms Labeling Approved
Methocarbamol
ANDA #203550
Methocarbamol Tablet; Oral SUPPL-1 Dbl Pharms Labeling Approved
Methocarbamol
ANDA #203550
Methocarbamol Tablet; Oral SUPPL-2 Dbl Pharms Labeling Approved
Ofloxacin
ANDA #078559
Ofloxacin Solution/Drops; Ophthalmic SUPPL-12 Fdc Ltd Labeling Approved
Olopatadine Hydrochloride
ANDA #078350
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-7 Apotex Labeling Approved
Olopatadine Hydrochloride
ANDA #078350
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-7 Apotex Labeling Approved
Omnipaque 12
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 12
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 9
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 9
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Rukobia
NDA #212950
Fostemsavir Tablet, Extended Release; Oral ORIG-1 Viiv Hlthcare Type 1 - New Molecular Entity Approved
Sumavel Dosepro
NDA #022239
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-7 Endo Ventures Ltd Labeling Approved
Tralement
NDA #209376
Trace Elements Injectable; Injection ORIG-1 American Regent Inc Type 4 - New Combination Approved
Visipaque 270
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Visipaque 270
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Pharm Inc Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-2 Par Pharm Inc Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Pharm Inc Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-2 Par Pharm Inc Labeling Approved

July 1, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Bumetanide
ANDA #074332
Bumetanide Injectable; Injection SUPPL-15 Hospira Labeling Approved
Butalbital, Acetaminophen and Caffeine
ANDA #213046
Acetaminophen; Butalbital; Caffeine Capsule; Oral ORIG-1 Taro Pharm Inds Ltd Approved
Doxepin Hydrochloride
ANDA #213063
Doxepin Hydrochloride Capsule; Oral ORIG-1 Taro Pharm Inds Ltd Approved
Furosemide
ANDA #213902
Furosemide Injectable; Injection ORIG-1 Gland Pharma Ltd Approved
Levorphanol Tartrate
ANDA #213479
Levorphanol Tartrate Tablet; Oral ORIG-1 Novitium Pharma Approved
Natpara
BLA #125511
Parathyroid Hormone Injectable; Injection SUPPL-20 Nps Pharms Inc Labeling Approved
Phenylephrine Hydrochloride
ANDA #213237
Phenylephrine Hydrochloride Solution; Intravenous ORIG-1 Accord Hlthcare Approved
Pradaxa
NDA #022512
Dabigatran Etexilate Mesylate Capsule; Oral SUPPL-39 Boehringer Ingelheim Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-14 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-8 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-9 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-14 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-3 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-1 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-2 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-3 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-4 Hikma Pharms Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-5 Dr Reddys Labs Inc Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-5 Dr Reddys Labs Inc Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-6 Dr Reddys Labs Inc Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-6 Dr Reddys Labs Inc Labeling Approved
Triamcinolone Acetonide
ANDA #213559
Triamcinolone Acetonide Lotion; Topical ORIG-1 Quagen Approved

June 30, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aveed
NDA #022219
Testosterone Undecanoate Injectable; Intramuscular SUPPL-14 Endo Pharms Inc Labeling Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection SUPPL-9 Emd Serono Inc Efficacy Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #207479
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Sciegen Pharms Inc Labeling Approved
Bupropion Hydrochloride
ANDA #207479
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Sciegen Pharms Inc Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #211020
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Graviti Pharms Labeling Approved
Dojolvi
NDA #213687
Triheptanoin Liquid; Oral ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved
Doxycycline Hyclate
ANDA #211744
Doxycycline Hyclate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Fortesta
NDA #021463
Testosterone Gel, Metered; Transdermal SUPPL-25 Endo Pharms Labeling Approved
Pantoprazole Sodium
ANDA #213725
Pantoprazole Sodium For Suspension, Delayed Release; Oral ORIG-1 Sun Pharm Approved
Retacrit
BLA #125545
Epoetin Alfa-Epbx Injectable; Injection SUPPL-5 Hospira Inc Efficacy Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-5 Watson Labs Inc Labeling Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-7 Watson Labs Inc Labeling Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-5 Watson Labs Inc Labeling Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-7 Watson Labs Inc Labeling Approved
Valsartan
ANDA #202728
Valsartan Tablet; Oral SUPPL-7 Torrent Labeling Approved
Valsartan
ANDA #202728
Valsartan Tablet; Oral SUPPL-6 Torrent Labeling Approved
Valsartan
ANDA #202728
Valsartan Tablet; Oral SUPPL-7 Torrent Labeling Approved

June 29, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5176 Genzyme Labeling Approved
Dacogen
NDA #021790
Decitabine Injectable; Intravenous SUPPL-25 Otsuka Pharm Co Ltd Labeling Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-26 Janssen Biotech Efficacy Approved
Fingolimod Hydrochloride
ANDA #207971
Fingolimod Hydrochloride Capsule; Oral ORIG-1 Strides Pharma Approved
Granisetron Hydrochloride
ANDA #202648
Granisetron Hydrochloride Injectable; Injection ORIG-1 Yung Shin Pharm Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-84 Merck Sharp Dohme Efficacy Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5176 Genzyme Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nitrogen, Nf
NDA #214858
Nitrogen Gas; Inhalation ORIG-1 Air Liquide Canada Inc Approved
Phesgo
BLA #761170
Pertuzumab;Trastuzumab;Hyaluronidase-Zzxf Injectable; Intravenous, Subcutaneous ORIG-1 Genentech Inc Type 4 - New Combination Approved
Potassium Citrate
ANDA #212799
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Bionpharma Inc Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-106 Bristol Myers Squibb Labeling Approved

July 7, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cervidil
NDA #020411
Dinoprostone Insert, Extended Release; Vaginal SUPPL-31 Ferring Pharms Inc Labeling Approved
Exondys 51
NDA #206488
Eteplirsen Solution; Intravenous SUPPL-19 Sarepta Theraps Inc Labeling Approved
Inqovi
NDA #212576
Decitabine;Cedazuridine Tablet; Oral ORIG-1 Astex Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Vibativ
NDA #022110
Telavancin Hydrochloride Powder; Intravenous SUPPL-16 Cumberland Pharms Labeling Approved

July 6, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cyclobenzaprine Hydrochloride
ANDA #213324
Cyclobenzaprine Hydrochloride Tablet; Oral ORIG-1 Unichem Labs Ltd Approved
Cyramza
BLA #125477
Ramucirumab Injectable; Injection SUPPL-37 Eli Lilly and Co Labeling Approved
Dalfampridine
ANDA #206858
Dalfampridine Tablet, Extended Release; Oral ORIG-1 Mylan Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-25 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-24 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078919
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-25 Zydus Pharms Usa Inc Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-23 Dr Reddys Labs Ltd Labeling Approved
Divalproex Sodium
ANDA #078979
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-23 Dr Reddys Labs Ltd Labeling Approved
Doxylamine Succinate and Pyridoxine Hydrochloride
ANDA #207825
Doxylamine Succinate; Pyridoxine Hydrochloride Tablet, Delayed Release; Oral ORIG-1 Mylan Pharms Inc Approved
Enalapril Maleate and Hydrochlorothiazide
ANDA #076486
Enalapril Maleate; Hydrochlorothiazide Tablet; Oral SUPPL-16 Nostrum Labs Inc Labeling Approved
Erythromycin
ANDA #212015
Erythromycin Tablet; Oral ORIG-1 Torrent Approved
Hulio
BLA #761154
Adalimumab-Fkjp Injectable; Injection ORIG-1 Mylan Pharms Inc Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-5 Novartis Efficacy Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet, Tablet; Oral SUPPL-8 Novartis Efficacy Approved
Levetiracetam In Sodium Chloride
ANDA #213532
Levetiracetam Injectable; Intravenous ORIG-1 Nexus Pharms Approved
Qwo
BLA #761146
Collagenase Clostridium Histolyticum-Aaes Injectable; Injection ORIG-1 Endo Global Aesthetics Ltd Approved
Rifampin
ANDA #206736
Rifampin Injectable; Injection SUPPL-1 Watson Pharms Teva Labeling Approved
Rifampin
ANDA #206736
Rifampin Injectable; Injection SUPPL-2 Watson Pharms Teva Labeling Approved
Rifampin
ANDA #206736
Rifampin Injectable; Injection SUPPL-3 Watson Pharms Teva Labeling Approved
Verapamil Hydrochloride
ANDA #212965
Verapamil Hydrochloride Injectable; Injection ORIG-1 Aurobindo Pharma Ltd Approved

July 2, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bendamustine Hydrochloride
NDA #212209
Bendamustine Hydrochloride Injectable; Injection ORIG-1 Slayback Pharma Llc Type 5 - New Formulation or New Manufacturer Tentative Approval
Byfavo
NDA #212295
Remimazolam Injectable; Injection ORIG-1 Cosmo Technologies Ltd Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Deferasirox
ANDA #210555
Deferasirox Tablet; Oral ORIG-2 Alkem Labs Ltd Approved
Erlotinib Hydrochloride
ANDA #211083
Erlotinib Hydrochloride Tablet; Oral ORIG-1 Accord Hlthcare Approved
Fingolimod Hydrochloride
ANDA #208008
Fingolimod Hydrochloride Capsule; Oral ORIG-1 Teva Pharms Usa Approved
Heparin Sodium
NDA #017029
Heparin Sodium Injectable; Injection SUPPL-156 Fresenius Kabi Usa Labeling Approved
Heparin Sodium
NDA #017651
Heparin Sodium Injectable; Injection SUPPL-66 Fresenius Kabi Usa Labeling Approved
Heparin Sodium In Plastic Container
NDA #017029
Heparin Sodium Injectable; Injection SUPPL-156 Fresenius Kabi Usa Labeling Approved
Heparin Sodium Preservative Free
NDA #017029
Heparin Sodium Injectable; Injection SUPPL-156 Fresenius Kabi Usa Labeling Approved
Methocarbamol
ANDA #040489
Methocarbamol Tablet; Oral SUPPL-15 Oxford Pharms Labeling Approved
Methocarbamol
ANDA #040489
Methocarbamol Tablet; Oral SUPPL-15 Oxford Pharms Labeling Approved
Methocarbamol
ANDA #203550
Methocarbamol Tablet; Oral SUPPL-2 Dbl Pharms Labeling Approved
Methocarbamol
ANDA #203550
Methocarbamol Tablet; Oral SUPPL-1 Dbl Pharms Labeling Approved
Methocarbamol
ANDA #203550
Methocarbamol Tablet; Oral SUPPL-2 Dbl Pharms Labeling Approved
Ofloxacin
ANDA #078559
Ofloxacin Solution/Drops; Ophthalmic SUPPL-12 Fdc Ltd Labeling Approved
Olopatadine Hydrochloride
ANDA #078350
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-7 Apotex Labeling Approved
Olopatadine Hydrochloride
ANDA #078350
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-7 Apotex Labeling Approved
Omnipaque 12
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 12
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 140
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 180
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 210
NDA #018956
Iohexol Injectable; Injection SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #018956
Iohexol Solution; Injection, Oral, Rectal SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #018956
Iohexol Solution; Injection, Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 70
NDA #018956
Iohexol Solution; Urethral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 9
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Omnipaque 9
NDA #018956
Iohexol Solution; Oral SUPPL-105 Ge Healthcare Labeling Approved
Rukobia
NDA #212950
Fostemsavir Tablet, Extended Release; Oral ORIG-1 Viiv Hlthcare Type 1 - New Molecular Entity Approved
Sumavel Dosepro
NDA #022239
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-7 Endo Ventures Ltd Labeling Approved
Tralement
NDA #209376
Trace Elements Injectable; Injection ORIG-1 American Regent Inc Type 4 - New Combination Approved
Visipaque 270
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Visipaque 270
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Visipaque 320
NDA #020351
Iodixanol Injectable; Injection SUPPL-50 Ge Healthcare Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Pharm Inc Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-2 Par Pharm Inc Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-1 Par Pharm Inc Labeling Approved
Zolpidem Tartrate
ANDA #204229
Zolpidem Tartrate Tablet; Sublingual SUPPL-2 Par Pharm Inc Labeling Approved

July 1, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Atorvastatin Calcium
ANDA #205519
Atorvastatin Calcium Tablet; Oral SUPPL-21 Sciegen Pharms Inc Labeling Approved
Bumetanide
ANDA #074332
Bumetanide Injectable; Injection SUPPL-15 Hospira Labeling Approved
Butalbital, Acetaminophen and Caffeine
ANDA #213046
Acetaminophen; Butalbital; Caffeine Capsule; Oral ORIG-1 Taro Pharm Inds Ltd Approved
Doxepin Hydrochloride
ANDA #213063
Doxepin Hydrochloride Capsule; Oral ORIG-1 Taro Pharm Inds Ltd Approved
Furosemide
ANDA #213902
Furosemide Injectable; Injection ORIG-1 Gland Pharma Ltd Approved
Levorphanol Tartrate
ANDA #213479
Levorphanol Tartrate Tablet; Oral ORIG-1 Novitium Pharma Approved
Natpara
BLA #125511
Parathyroid Hormone Injectable; Injection SUPPL-20 Nps Pharms Inc Labeling Approved
Phenylephrine Hydrochloride
ANDA #213237
Phenylephrine Hydrochloride Solution; Intravenous ORIG-1 Accord Hlthcare Approved
Pradaxa
NDA #022512
Dabigatran Etexilate Mesylate Capsule; Oral SUPPL-39 Boehringer Ingelheim Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-14 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-8 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-9 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-14 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-3 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-1 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-2 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-3 Hikma Pharms Labeling Approved
Rifampin
ANDA #205039
Rifampin Injectable; Injection SUPPL-4 Hikma Pharms Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-5 Dr Reddys Labs Inc Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-5 Dr Reddys Labs Inc Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-6 Dr Reddys Labs Inc Labeling Approved
Sumatriptan Succinate
ANDA #076847
Sumatriptan Succinate Tablet; Oral SUPPL-6 Dr Reddys Labs Inc Labeling Approved
Triamcinolone Acetonide
ANDA #213559
Triamcinolone Acetonide Lotion; Topical ORIG-1 Quagen Approved

June 30, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aveed
NDA #022219
Testosterone Undecanoate Injectable; Intramuscular SUPPL-14 Endo Pharms Inc Labeling Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection SUPPL-9 Emd Serono Inc Efficacy Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #206556
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-14 Invagen Pharms Labeling Approved
Bupropion Hydrochloride
ANDA #207479
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Sciegen Pharms Inc Labeling Approved
Bupropion Hydrochloride
ANDA #207479
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Sciegen Pharms Inc Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #208652
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Sinotherapeutics Inc Labeling Approved
Bupropion Hydrochloride
ANDA #211020
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Graviti Pharms Labeling Approved
Dojolvi
NDA #213687
Triheptanoin Liquid; Oral ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved
Doxycycline Hyclate
ANDA #211744
Doxycycline Hyclate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved
Fortesta
NDA #021463
Testosterone Gel, Metered; Transdermal SUPPL-25 Endo Pharms Labeling Approved
Pantoprazole Sodium
ANDA #213725
Pantoprazole Sodium For Suspension, Delayed Release; Oral ORIG-1 Sun Pharm Approved
Retacrit
BLA #125545
Epoetin Alfa-Epbx Injectable; Injection SUPPL-5 Hospira Inc Efficacy Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-5 Watson Labs Inc Labeling Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-7 Watson Labs Inc Labeling Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-5 Watson Labs Inc Labeling Approved
Valsartan
ANDA #090642
Valsartan Tablet; Oral SUPPL-7 Watson Labs Inc Labeling Approved
Valsartan
ANDA #202728
Valsartan Tablet; Oral SUPPL-7 Torrent Labeling Approved
Valsartan
ANDA #202728
Valsartan Tablet; Oral SUPPL-6 Torrent Labeling Approved
Valsartan
ANDA #202728
Valsartan Tablet; Oral SUPPL-7 Torrent Labeling Approved

June 29, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5176 Genzyme Labeling Approved
Dacogen
NDA #021790
Decitabine Injectable; Intravenous SUPPL-25 Otsuka Pharm Co Ltd Labeling Approved
Darzalex
BLA #761036
Daratumumab Injectable; Injection SUPPL-26 Janssen Biotech Efficacy Approved
Fingolimod Hydrochloride
ANDA #207971
Fingolimod Hydrochloride Capsule; Oral ORIG-1 Strides Pharma Approved
Granisetron Hydrochloride
ANDA #202648
Granisetron Hydrochloride Injectable; Injection ORIG-1 Yung Shin Pharm Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-84 Merck Sharp Dohme Efficacy Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5176 Genzyme Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nevirapine
ANDA #078644
Nevirapine Tablet; Oral SUPPL-5 Prinston Inc Labeling Approved
Nitrogen, Nf
NDA #214858
Nitrogen Gas; Inhalation ORIG-1 Air Liquide Canada Inc Approved
Phesgo
BLA #761170
Pertuzumab;Trastuzumab;Hyaluronidase-Zzxf Injectable; Intravenous, Subcutaneous ORIG-1 Genentech Inc Type 4 - New Combination Approved
Potassium Citrate
ANDA #212799
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Bionpharma Inc Approved
Yervoy
BLA #125377
Ipilimumab Injectable; Injection SUPPL-106 Bristol Myers Squibb Labeling Approved

June 26, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cytarabine
ANDA #206189
Cytarabine Injectable; Injection ORIG-1 Hong Kong Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #203263
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-27 Sun Pharm Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #203263
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-27 Sun Pharm Labeling Approved
Doxorubicin Hydrochloride (Liposomal)
ANDA #208657
Doxorubicin Hydrochloride Injectable, Liposomal; Injection SUPPL-4 Dr Reddys Labs Ltd Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-74 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Injection SUPPL-75 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-74 Pfizer Inc Labeling Approved
Fragmin
NDA #020287
Dalteparin Sodium Injectable; Subcutaneous SUPPL-75 Pfizer Inc Labeling Approved
Lialda
NDA #022000
Mesalamine Tablet, Delayed Release; Oral SUPPL-19 Shire Efficacy Approved
Mycapssa
NDA #208232
Octreotide Acetate Capsule, Delayed Release; Oral ORIG-1 Chiasma Type 5 - New Formulation or New Manufacturer Approved

June 25, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amoxicillin
ANDA #205274
Amoxicillin Tablet, Chewable; Oral ORIG-1 Hikma Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-14 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-8 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-9 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-10 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-11 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-12 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-13 Mylan Labeling Approved
Divalproex Sodium
ANDA #090407
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral SUPPL-14 Mylan Labeling Approved
Esomeprazole Magnesium
ANDA #212088
Esomeprazole Magnesium Tablet, Delayed Release; Oral ORIG-1 Mylan Approved
Fintepla
NDA #212102
Fenfluramine Hydrochloride Solution; Oral ORIG-1 Zogenix Inc Type 3 - New Dosage Form Approved
Haloperidol Decanoate
ANDA #075393
Haloperidol Decanoate Injectable; Injection SUPPL-33 Teva Pharms Usa Labeling Approved
Haloperidol Decanoate
ANDA #075393
Haloperidol Decanoate Injectable; Injection SUPPL-33 Teva Pharms Usa Labeling Approved
Libtayo
BLA #761097
Cemiplimab-Rwlc Injectable; Intravenous SUPPL-5 Regeneron Pharmaceuticals Efficacy Approved
Nitroglycerin
ANDA #087355
Nitroglycerin Ointment; Transdermal SUPPL-33 Fougera Pharms Inc Labeling Approved
Prochlorperazine Edisylate
ANDA #204147
Prochlorperazine Edisylate Injectable; Injection SUPPL-25 Emcure Pharms Ltd Labeling Approved
Propafenone Hydrochloride
ANDA #212744
Propafenone Hydrochloride Capsule, Extended Release; Oral ORIG-1 Upsher Smith Labs Approved
Rocuronium Bromide
ANDA #091458
Rocuronium Bromide Injectable; Injection SUPPL-13 Sagent Pharms Inc Labeling Approved
Rocuronium Bromide
ANDA #091458
Rocuronium Bromide Injectable; Injection SUPPL-13 Sagent Pharms Inc Labeling Approved
Sumatriptan Succinate
ANDA #200263
Sumatriptan Succinate Tablet; Oral SUPPL-1 Corepharma Labeling Approved
Tranexamic Acid
ANDA #201580
Tranexamic Acid Injectable; Injection SUPPL-3 Xgen Pharms Labeling Approved

June 24, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-36 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-37 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-35 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-36 Teva Pharms Labeling Approved
Amiodarone Hydrochloride
ANDA #074739
Amiodarone Hydrochloride Tablet; Oral SUPPL-37 Teva Pharms Labeling Approved
Ammonia N 13
ANDA #203779
Ammonia N-13 Injectable; Intravenous SUPPL-1 3d Imaging Drug Manufacturing (CMC) Approved
Asparlas
BLA #761102
Calaspargase Pegol-Mknl Injectable; Intravenous SUPPL-3 Servier Pharma Llc Labeling Approved
Atacand
NDA #020838
Candesartan Cilexetil Tablet; Oral SUPPL-41 Ani Pharms Inc Labeling Approved
Atropine Sulfate Ansyr Plastic Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous, Intramuscular, Subcutaneous, Endotracheal SUPPL-22 Hospira Labeling Approved
Atropine Sulfate Ansyr Plastic Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous, Intramuscular, Subcutaneous, Endotracheal SUPPL-22 Hospira Labeling Approved
Atropine Sulfate Lifeshield Abboject Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous SUPPL-22 Hospira Labeling Approved
Atropine Sulfate Lifeshield Abboject Syringe
NDA #021146
Atropine Sulfate Solution; Intravenous SUPPL-22 Hospira Labeling Approved
Benazepril Hydrochloride
ANDA #076344
Benazepril Hydrochloride Tablet; Oral SUPPL-18 Sun Pharm Inds Ltd Labeling Approved
Dexmedetomidine Hydrochloride
ANDA #205867
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-1 Aurobindo Pharma Ltd Labeling Approved
Dexmedetomidine Hydrochloride
ANDA #205867
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Dexmedetomidine Hydrochloride
ANDA #205867
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-4 Aurobindo Pharma Ltd Labeling Approved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #211876
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Mylan Approved
Drizalma Sprinkle
NDA #212516
Duloxetine Hydrochloride Capsule, Delayed Release; Oral SUPPL-1 Sun Pharma Global Labeling Approved
Fludeoxyglucose F18
ANDA #203778
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-2 3d Imaging Drug Manufacturing (CMC) Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-92 Merck Sharp Dohme Efficacy Approved
Keytruda
BLA #125514
Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-68 Merck Sharp Dohme Efficacy Approved
Nevirapine
ANDA #078584
Nevirapine Tablet; Oral SUPPL-18 Hetero Labs Ltd Iii Labeling Approved
Nevirapine
ANDA #078584
Nevirapine Tablet; Oral SUPPL-19 Hetero Labs Ltd Iii Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved
Pitavastatin Calcium
ANDA #206015
Pitavastatin Calcium Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved
Prasugrel
ANDA #205927
Prasugrel Hydrochloride Tablet; Oral SUPPL-3 Mylan Labeling Approved
Prasugrel
ANDA #205927
Prasugrel Hydrochloride Tablet; Oral SUPPL-3 Mylan Labeling Approved
Prednisone
ANDA #213386
Prednisone Tablet; Oral ORIG-1 Amneal Approved
Procysbi
NDA #203389
Cysteamine Bitartrate Capsule, Delayed Release; Oral SUPPL-23 Horizon Pharma Usa Labeling Approved
Procysbi
NDA #203389
Cysteamine Bitartrate Capsule, Delayed Release; Oral SUPPL-23 Horizon Pharma Usa Labeling Approved
Sodium Fluoride F-18
ANDA #203777
Sodium Fluoride F-18 Injectable; Intravenous SUPPL-1 3d Imaging Drug Manufacturing (CMC) Approved
Sumatriptan and Naproxen Sodium
ANDA #207457
Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Sumatriptan and Naproxen Sodium
ANDA #207457
Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved

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