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FDA · 14,051 results Live
FDA CENTAUR Feb 23 — 0.00

FDA Approves Unknown Drug — CENTAUR PHARMS PVT

# FDA Approves New Generic Drug Application for Centaur Pharmaceuticals The FDA has approved ANDA220470 for Centaur Pharmaceuticals PVT, expanding the company's portfolio and pote…

FDA PAI Feb 23 — 0.00

FDA Approves BRIVARACETAM — PAI Holdings, LLC dba PAI Pharma

# FDA Approves Brivaracetam Injection Generic, Expanding Market Competition PAI Pharma has received FDA approval for its generic brivaracetam injection, an intravenous formulation…

FDA Florida Feb 23 — 0.00

FDA Approves BRIVARACETAM ORAL SOLUTION — Florida Pharmaceutical Products, LLC

# FDA Approves Generic Brivaracetam Oral Solution by Florida Pharmaceutical Products Florida Pharmaceutical Products, LLC has received FDA approval for a generic version of brivar…

FDA Zhejiang Feb 23 — 0.00

FDA Approves BRIVARACETAM — Zhejiang Poly Pharm. Co., Ltd.

Zhejiang Poly Pharm Co., Ltd. secured FDA approval for its generic oral formulation of Brivaracetam, granting the manufacturer a competitive foothold in the neurological market and…

FDA INVAGEN Feb 20 — 0.00

FDA Approves Unknown Drug — INVAGEN PHARMS

# FDA Approves ANDA Application for INVAGEN PHARMS InvaGen Pharmaceuticals has received FDA approval for ANDA218768, expanding its generic drug portfolio and positioning the compa…

FDA VANDA Feb 20 — 0.00

FDA Approves Unknown Drug — VANDA PHARMS INC

# FDA Approves Vanda Pharmaceuticals' New Drug Application The FDA has approved NDA 220358 for Vanda Pharmaceuticals Inc., potentially expanding the company's product portfolio an…

FDA Avyxa Feb 20 — 0.00

FDA Approves FAVLYXA — Avyxa Pharma, LLC

# FDA Approves Avyxa Pharma's FAVLYXA (Fluorouracil) for Intravenous Use The FDA has approved Avyxa Pharma's FAVLYXA (fluorouracil) for intravenous administration, marking the com…

FDA AVET Feb 19 — 0.00

FDA Approves Unknown Drug — AVET LIFESCIENCES

# FDA Approves AVET Lifesciences Generic Drug Application AVET Lifesciences has received FDA approval for ANDA203276, marking the company's entry into an additional generic drug m…

FDA Micro Feb 17 — 0.00

FDA Approves COLCHICINE — Micro Labs Limited

# FDA Approves Colchicine Generic From Micro Labs Limited Micro Labs Limited received FDA approval for its generic colchicine oral formulation, expanding the competitive landscape…

FDA Janssen Feb 13 — 0.00

FDA Approves RYBREVANT FASPRO — Janssen Biotech, Inc.

# FDA Approves Janssen's RYBREVANT FASPRO Subcutaneous Formulation The FDA has approved Janssen Biotech's RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), a subcutaneous for…

FDA ZYDUS Feb 12 — 0.00

FDA Approves Unknown Drug — ZYDUS LIFESCIENCES

# FDA Approves Zydus Lifesciences Generic Drug Application Zydus Lifesciences has received FDA approval for ANDA217815, expanding the company's generic drug portfolio and position…

FDA AJENAT Feb 11 — 0.00

FDA Approves GLATIRAMER ACETATE — AJENAT PHARMACEUTICALS LLC

# FDA Approves Generic Glatiramer Acetate for Ajenat Pharmaceuticals Ajenat Pharmaceuticals LLC has received FDA approval for its generic glatiramer acetate injection (ANDA213382)…

FDA Encube Feb 10 — 0.00

FDA Approves TRETINOIN — Encube Ethicals, Inc.

# FDA Approves Encube Ethicals' Generic Tretinoin Topical Formulation The U.S. Food and Drug Administration has approved Encube Ethicals, Inc.'s abbreviated new drug application f…

FDA HIKMA Feb 10 — 0.00

FDA Approves Unknown Drug — HIKMA

On February 10, 2026, Hikma announced regulatory approval for a generic drug through ANDA205057, signaling a strategic precedent for future portfolio initiatives despite the absenc…

FDA Gland Feb 5 — 0.00

FDA Approves ZOLEDRONIC ACID — Gland Pharma Limited

# FDA Approves Gland Pharma's Generic Zoledronic Acid Gland Pharma Limited has received FDA approval for its generic zoledronic acid intravenous formulation, expanding the competi…

FDA Alembic Feb 5 — 0.00

FDA Approves CARBIDOPA, LEVODOPA AND ENTACAPONE — Alembic Pharmaceuticals Inc.

# FDA Approves Generic Carbidopa, Levodopa and Entacapone from Alembic Pharmaceuticals Alembic Pharmaceuticals Inc. received FDA approval for a generic version of carbidopa, levod…

FDA CIPLA Feb 2 — 0.00

FDA Approves Unknown Drug — CIPLA

# FDA Approves CIPLA's Generic Drug Application Cipla Limited received FDA approval for its abbreviated new drug application (ANDA 213165) on February 2, 2026, positioning the com…

FDA Somerset Jan 29 — 0.00

FDA Approves RILPIVIRINE — Somerset Therapeutics, LLC

# FDA Approves Somerset Therapeutics' Generic Rilpivirine Somerset Therapeutics, LLC has received FDA approval for its generic rilpivirine hydrochloride oral formulation (ANDA2187…

FDA Alembic Jan 26 — 0.00

FDA Approves DIFLUPREDNATE — Alembic Pharmaceuticals Inc.

# FDA Approves Generic Difluprednate Ophthalmic from Alembic Pharmaceuticals The FDA has approved Alembic Pharmaceuticals' generic difluprednate ophthalmic formulation, expanding …

FDA NOVITIUM Jan 26 — 0.00

FDA Approves Unknown Drug — NOVITIUM PHARMA

Novitium Pharma secured FDA approval for its ANDA 219119, a milestone anticipated to accelerate revenue generation and strengthen the company's competitive market position.