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Feb 25 FDA Approves CETIRIZINE HYDROCHLORIDE — Advagen Pharma Ltd.,Feb 24 FDA Approves Unknown Drug — YICHANG HUMANWELLFeb 23 FDA Approves BRIVARACETAM — Micro Labs LimitedFeb 23 FDA Approves Unknown Drug — CENTAUR PHARMS PVTFeb 23 FDA Approves BRIVARACETAM — PAI Holdings, LLC dba PAI Pharma
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FDA · 35,187 results Live
FDA Advagen Feb 25 — 0.00

FDA Approves CETIRIZINE HYDROCHLORIDE — Advagen Pharma Ltd.,

# FDA Approves Generic Cetirizine Hydrochloride for Advagen Pharma Ltd. Advagen Pharma Ltd. has received FDA approval for its generic cetirizine hydrochloride oral formulation (AN…

FDA YICHANG Feb 24 — 0.00

FDA Approves Unknown Drug — YICHANG HUMANWELL

# FDA Approves ANDA for Yichang Humanwell The FDA has approved ANDA219518 for Yichang Humanwell, marking the company's entry into the U.S. generic drug market and potentially incr…

FDA Micro Feb 23 — 0.00

FDA Approves BRIVARACETAM — Micro Labs Limited

# FDA Approves Generic Brivaracetam Intravenous Formulation Micro Labs Limited has received FDA approval for a generic intravenous brivaracetam formulation (ANDA214880), marking a…

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 Sagent Feb 3 ▲ +0.50

FDA Approves DOXORUBICIN HYDROCHLORIDE LIPOSOME — Sagent Pharmaceuticals

On February 3, 2026, Sagent Pharmaceuticals announced the FDA approval of its Abbreviated New Drug Application for generic doxorubicin hydrochloride liposome, addressing a high-val…