Final Approvals
Cefazolin Sodium Injection: Cephazone Pharma
Fluoxetine Capsules: Alembic Limited, Approval
Minocycline Hydrochloride Extended-Release Tablets: Barr Labs
Pantoprazole Sodium Delayed-Release Tablets: KUDCO Ireland Limited
Prednisolone Sodium Phosphate Oral Solution: Amneal Pharmaceuticals
Levetiracetam Tablets: Apotex
Zolpidem tartrate Tablets: Orexo AB
Apraclonidine Hydrochloride Ophthalmic Solution: Akorn
Omeprazole Delayed-Release Capsules: Dr. Reddy's
Indomethacin Extended-Release Capsules: Avanthi
Leuprolide Acetate Injection: Sun Pharma Global, Inc., Approval
Malathion Lotion: Synerx Pharma
Propranolol Hydochloride Extended-Release Capsules: Upsher-Smith
Ramipril Capsules: Ranbaxy
Glycopyrrolate Tablets:West-ward Pharmaceutical Corp
Methylprednisolone Acetate Injection: Sandoz
Quinapril Hydrochloride and Hydrochlorothiazide Tablets: Ranbaxy
Sertraline Hydrochloride Tablets: AustraPharma
Buspirone Hydrochloride Tablets: Dr. Reddy’s Lab
Citalopram Hydrobrobromide Tablets: Glenmark Generics
Nabumetone Tablets: Actavis Elizabeth
Temodar (Temozolomide) Injection: Schering Corp
Divalproex Sodium Extended-Release Tablets: Zydus Pharma., Mylan, Anchen Pharma (Taiwan)
Granisetron Hydrochloride Tablets: Dr. Reddy's Labs
Carboplatin I.V. Injection: Pharmachemie B.V.
Azelastine Hydrochloride Ophthalmic Solution: ApotexCefazolin Sodium Injection: Cephazone Pharma
Fluoxetine Capsules: Alembic Limited, Approval
Minocycline Hydrochloride Extended-Release Tablets: Barr Labs
Pantoprazole Sodium Delayed-Release Tablets: KUDCO Ireland Limited
Prednisolone Sodium Phosphate Oral Solution: Amneal Pharmaceuticals
Levetiracetam Tablets: Apotex
Zolpidem tartrate Tablets: Orexo AB
Apraclonidine Hydrochloride Ophthalmic Solution: Akorn
Omeprazole Delayed-Release Capsules: Dr. Reddy's
Indomethacin Extended-Release Capsules: Avanthi
Leuprolide Acetate Injection: Sun Pharma Global, Inc., Approval
Malathion Lotion: Synerx Pharma
Propranolol Hydochloride Extended-Release Capsules: Upsher-Smith
Ramipril Capsules: Ranbaxy
Glycopyrrolate Tablets:West-ward Pharmaceutical Corp
Methylprednisolone Acetate Injection: Sandoz
Quinapril Hydrochloride and Hydrochlorothiazide Tablets: Ranbaxy
Sertraline Hydrochloride Tablets: AustraPharma
Buspirone Hydrochloride Tablets: Dr. Reddy’s Lab
Citalopram Hydrobrobromide Tablets: Glenmark Generics
Nabumetone Tablets: Actavis Elizabeth
Temodar (Temozolomide) Injection: Schering Corp
Divalproex Sodium Extended-Release Tablets: Zydus Pharma., Mylan, Anchen Pharma (Taiwan)
Granisetron Hydrochloride Tablets: Dr. Reddy's Labs
Carboplatin I.V. Injection: Pharmachemie B.V.
Bupropion Hydrochloride Extended-Release Tablets: Watson Laboratories
Flumazenil Injection: Hikma Farmaceutica (Portugal)
Ibuprofen Capsules: Banner Pharmacaps
Risperidone Tablets: Cadista Pharmaceuticals
Sulfacetamide Sodium Lotion: Perrigo
Levetiracetam Tablets: Cipla
Stavudine Oral Solution: Cipla LtdLevalbuterol Inhalation Solution: Dey
Tentative Approval
Lopinavir and Ritonavir Tablets: Aurobindo Pharma and Matrix Labs
Lopinavir and Ritonavir Tablets: Aurobindo Pharma and Matrix Labs
Lamivudine Tablets: Alkem Labs
Ketorolac Tromethamine Ophthalmic Solution: Alcon, Inc.
Rosiglitazone Maleate Tablets: Sandoz Inc.
Ketorolac Tromethamine Ophthalmic Solution: Alcon, Inc.
Rosiglitazone Maleate Tablets: Sandoz Inc.
Stavudine, Lamivudine and Nevirapine Tablets: Pharmacare Ltd.
(Source: USFDA)
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