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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