August 8, 2019
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.August 8, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Tikosyn NDA #020931 | Dofetilide | Capsule; Oral | SUPPL-17 | Pfizer | Labeling | Approved |
| Xultophy 100/3.6 NDA #208583 | Insulin Degludec; Liraglutide | Solution; Subcutaneous | SUPPL-12 | Novo | Labeling | Approved |
| Zoledronic Acid ANDA #209578 | Zoledronic Acid | Unknown | ORIG-1 | Gland Pharma Ltd | Approved | |
| Clenpiq NDA #209589 | Citric Acid; Magnesium Oxide; Sodium Picosulfate | Solution; Oral | SUPPL-5 | Ferring Pharms Inc | Efficacy | Approved |
August 7, 2019
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Imodium A-D NDA #019487 | Loperamide Hydrochloride | Solution; Oral | SUPPL-34 | J and J Consumer Inc | Labeling | Approved |
| Imodium A-D NDA #019487 | Loperamide Hydrochloride | Suspension; Oral | SUPPL-34 | J and J Consumer Inc | Labeling | Approved |
| Zyrtec Allergy NDA #019835 | Cetirizine Hydrochloride | Tablet; Oral | SUPPL-40 | J and J Consumer Inc | Labeling | Approved |
| Zyrtec Hives Relief NDA #019835 | Cetirizine Hydrochloride | Tablet; Oral | SUPPL-40 | J and J Consumer Inc | Labeling | Approved |
| Aleve NDA #020204 | Naproxen Sodium | Tablet; Oral | SUPPL-68 | Bayer | Labeling | Approved |
| Abilify NDA #021436 | Aripiprazole | Tablet; Oral | SUPPL-43 | Otsuka | Labeling | Approved |
| Ranexa NDA #021526 | Ranolazine | Tablet, Extended Release; Oral | SUPPL-35 | Gilead | Labeling | Approved |
| Ranexa NDA #021526 | Ranolazine | Tablet, Extended Release; Oral | SUPPL-34 | Gilead | Labeling | Approved |
| Abilify NDA #021713 | Aripiprazole | Solution; Oral | SUPPL-34 | Otsuka | Labeling | Approved |
| Abilify NDA #021729 | Aripiprazole | Tablet, Orally Disintegrating; Oral | SUPPL-26 | Otsuka | Labeling | Approved |
| Novolog Mix 50/50 NDA #021810 | Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant | Injectable; Subcutaneous | SUPPL-17 | Novo Nordisk Inc | Labeling | Approved |
| Abilify NDA #021866 | Aripiprazole | Injectable; Intramuscular | SUPPL-28 | Otsuka | Labeling | Approved |
| Enalapril Maleate ANDA #075657 | Enalapril Maleate | Tablet; Oral | SUPPL-15 | Taro | Labeling | Approved |
| Enalapril Maleate ANDA #075657 | Enalapril Maleate | Tablet; Oral | SUPPL-17 | Taro | Labeling | Approved |
| Simvastatin ANDA #077691 | Simvastatin | Tablet; Oral | SUPPL-38 | Aurobindo Pharma | Labeling | Approved |
| Simvastatin ANDA #077837 | Simvastatin | Tablet; Oral | SUPPL-38 | Zydus Pharms Usa | Labeling | Approved |
| Simvastatin ANDA #077837 | Simvastatin | Tablet; Oral | SUPPL-39 | Zydus Pharms Usa | Labeling | Approved |
| Bisoprolol Fumarate ANDA #078635 | Bisoprolol Fumarate | Tablet; Oral | SUPPL-17 | Unichem Pharms (Usa) | Labeling | Approved |
| Benazepril Hydrochloride ANDA #078848 | Benazepril Hydrochloride | Tablet; Oral | SUPPL-5 | Zydus Pharms Usa | Labeling | Approved |
| Irbesartan and Hydrochlorothiazide ANDA #090351 | Hydrochlorothiazide; Irbesartan | Tablet; Oral | SUPPL-5 | West-Ward Pharms Int | Labeling | Approved |
| Irbesartan and Hydrochlorothiazide ANDA #090351 | Hydrochlorothiazide; Irbesartan | Tablet; Oral | SUPPL-8 | West-Ward Pharms Int | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-9 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-10 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-11 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-13 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-14 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-8 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-9 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-10 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-11 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-13 | Dr Reddys Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate ANDA #091023 | Clopidogrel Bisulfate | Tablet; Oral | SUPPL-14 | Dr Reddys Labs Ltd | Labeling | Approved |
| Reopro BLA #103575 | Abciximab | Injectable; Injection | SUPPL-5318 | Centocor Inc | Labeling | Approved |
| Reopro BLA #103575 | Abciximab | Injectable; Injection | SUPPL-5138 | Centocor Inc | Labeling | Approved |
| Telmisartan ANDA #203171 | Telmisartan | Tablet; Oral | SUPPL-6 | Torrent | Labeling | Approved |
| Telmisartan ANDA #203171 | Telmisartan | Tablet; Oral | SUPPL-6 | Torrent | Labeling | Approved |
| Omega-3-Acid Ethyl Esters ANDA #206455 | Omega-3-Acid Ethyl Esters | Capsule; Oral | ORIG-1 | Bionpharma Inc | Approved | |
| Celecoxib ANDA #208856 | Celecoxib | Capsule; Oral | ORIG-1 | Qingdao Baheal Pharm | Approved | |
| Doxercalciferol ANDA #208974 | Doxercalciferol | Injectable; Injection | SUPPL-3 | Amneal Pharms Co | Labeling | Approved |
| Doxercalciferol ANDA #208974 | Doxercalciferol | Injectable; Injection | SUPPL-3 | Amneal Pharms Co | Labeling | Approved |
| Doxercalciferol ANDA #208975 | Doxercalciferol | Injectable; Injection | SUPPL-3 | Amneal Pharms Co | Labeling | Approved |
| Doxercalciferol ANDA #208975 | Doxercalciferol | Injectable; Injection | SUPPL-3 | Amneal Pharms Co | Labeling | Approved |
| Atorvastatin Calcium ANDA #209912 | Atorvastatin Calcium | Tablet; Oral | SUPPL-2 | Graviti Pharms | Labeling | Approved |
| Atorvastatin Calcium ANDA #209912 | Atorvastatin Calcium | Tablet; Oral | SUPPL-6 | Graviti Pharms | Labeling | Approved |
| Bimatoprost ANDA #210144 | Bimatoprost | Unknown | ORIG-1 | Alembic Pharms Ltd | Tentative Approval | |
| Ranitidine Hydrochloride ANDA #211289 | Ranitidine Hydrochloride | Tablet; Oral | SUPPL-1 | Vkt Pharma Pvt Ltd | Manufacturing (CMC) | Approved |
| Ranitidine Hydrochloride ANDA #211289 | Ranitidine Hydrochloride | Tablet; Oral | SUPPL-1 | Vkt Pharma Pvt Ltd | Manufacturing (CMC) | Approved |
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