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Mar 6 FDA Approves GABAPENTIN — Solco Healthcare US, LLCMar 6 FDA Approves Unknown Drug — AUROBINDO PHARMA LTDMar 5 FDA Approves Unknown Drug — MYLANMar 5 FDA Approves OLANZAPINE — GLENMARK PHARMACEUTICALS INC., USAMar 5 FDA Approves CHILDRENS IBUPROFEN — Advagen Pharma Ltd.
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FDA · 34,986 results Live
FDA Solco Mar 6 — 0.00

FDA Approves GABAPENTIN — Solco Healthcare US, LLC

# FDA Approves Solco Healthcare's Generic Gabapentin The FDA has approved Solco Healthcare US, LLC's abbreviated new drug application for generic gabapentin oral formulation, expa…

FDA AUROBINDO Mar 6 — 0.00

FDA Approves Unknown Drug — AUROBINDO PHARMA LTD

# FDA Approves Aurobindo Pharma Generic Drug Application The U.S. Food and Drug Administration has approved Aurobindo Pharma Ltd.'s abbreviated new drug application (ANDA218459) a…

FDA MYLAN Mar 5 — 0.00

FDA Approves Unknown Drug — MYLAN

# FDA Approves Mylan ANDA Application Mylan received FDA approval for ANDA218851 on March 5, 2026, expanding the company's generic drug portfolio and positioning it to capture add…

FDA GLENMARK Mar 5 — 0.00

FDA Approves OLANZAPINE — GLENMARK PHARMACEUTICALS INC., USA

# FDA Approves Glenmark Pharmaceuticals' Generic Olanzapine Injection, Expanding Long-Acting Antipsychotic Market The FDA has approved Glenmark Pharmaceuticals Inc.'s abbreviated …

FDA Advagen Mar 5 — 0.00

FDA Approves CHILDRENS IBUPROFEN — Advagen Pharma Ltd.

# FDA Approves Advagen Pharma's Generic Children's Ibuprofen Advagen Pharma Ltd. received FDA approval for its generic Children's Ibuprofen oral formulation (ANDA220239) on March …

FDA Zydus Mar 4 — 0.00

FDA Approves CALCITONIN SALMON — Zydus Pharmaceuticals USA Inc.

# FDA Approves Zydus Pharmaceuticals' Generic Calcitonin Salmon Injection The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic calcitonin salmon intramuscular injection (…

FDA ASPIRO Mar 4 — 0.00

FDA Approves Unknown Drug — ASPIRO

# FDA Approves ASPIRO's Generic Drug Application ASPIRO has received FDA approval for its abbreviated new drug application (ANDA 220124), expanding the company's generic pharmaceu…

FDA Macleods Mar 2 — 0.00

FDA Approves MOXIFLOXACIN — Macleods Pharmaceuticals Limited

# FDA Approves Generic Moxifloxacin ANDA from Macleods Pharmaceuticals Macleods Pharmaceuticals Limited has received FDA approval for its generic moxifloxacin hydrochloride oral f…

FDA EPIC Mar 2 — 0.00

FDA Approves Unknown Drug — EPIC PHARMA LLC

# FDA Approves Epic Pharma's Generic Drug Application Epic Pharma LLC has received FDA approval for an abbreviated new drug application (ANDA 219556), marking another addition to …

FDA JANSSEN Feb 27 — 0.00

FDA Approves Unknown Drug — JANSSEN PRODS

# FDA Approves Janssen Product, Expanding Company's Portfolio Janssen Products received FDA approval for a new therapeutic agent under NDA 220092, potentially strengthening the ph…

FDA Ascendis Feb 27 — 0.00

FDA Approves YUVIWEL — Ascendis Pharma Endocrinology, Inc.

# FDA Approves Ascendis Pharma's YUVIWEL (navepegritide), Marking Entry Into Growth Hormone Deficiency Market Ascendis Pharma Endocrinology, Inc. received FDA approval for YUVIWEL…

FDA Caplin Feb 27 — 0.00

FDA Approves DESMOPRESSIN ACETATE — Caplin Steriles Limited

# FDA Approves Caplin Steriles' Intravenous Desmopressin Acetate Caplin Steriles Limited has received FDA approval for its generic intravenous desmopressin acetate formulation (AN…

FDA Macleods Feb 27 — 0.00

FDA Approves DILTIAZEM HYDROCHLORIDE — Macleods Pharmaceuticals Limited

Macleods Pharmaceuticals Limited announced the FDA’s approval of its generic Diltiazem Hydrochloride oral tablets on February 27, 2026, facilitating the company’s expansion into th…

FDA Almatica Feb 27 ▲ +0.40

FDA Approves DULOXETINE — Almatica Pharma LLC

Almatica Pharma LLC announced today that the U.S. FDA has approved a supplemental New Drug Application for duloxetine hydrochloride, oral, setting a final market exit date for the …

FDA SINOTHERAPEUTICS Feb 26 — 0.00

FDA Approves Unknown Drug — SINOTHERAPEUTICS INC

# FDA Approves ANDA for SinoTherapeutics Inc SinoTherapeutics Inc has received FDA approval for ANDA220454, marking the company's entry into the generic drug market and positionin…

FDA Viona Feb 26 — 0.00

FDA Approves DAPSONE — Viona Pharmaceuticals Inc

# FDA Approves Viona Pharmaceuticals' Generic Dapsone Viona Pharmaceuticals Inc. received FDA approval for its generic dapsone oral formulation, expanding treatment options for pa…

FDA Zydus Feb 26 — 0.00

FDA Approves IVERMECTIN — Zydus Lifesciences Limited

# FDA Approves Zydus Lifesciences' Generic Ivermectin Oral Formulation Zydus Lifesciences Limited received FDA approval for its generic ivermectin oral formulation, expanding the …

FDA Aurobindo Feb 25 — 0.00

FDA Approves EVEROLIMUS — Aurobindo Pharma Limited

# FDA Approves Aurobindo Pharma's Generic Everolimus, Expanding Competitive Landscape for Immunosuppressant Market The U.S. Food and Drug Administration has approved Aurobindo Pha…

FDA DR Feb 25 — 0.00

FDA Approves Unknown Drug — DR REDDYS

# FDA Approves Dr. Reddy's Generic Drug Application Dr. Reddy's Laboratories has received FDA approval for ANDA220315, marking another addition to the company's generic drug portf…

FDA APPCO Feb 25 — 0.00

FDA Approves Unknown Drug — APPCO

# FDA Approves APPCO's Generic Drug Application APPCO has received FDA approval for an abbreviated new drug application (ANDA 220329), expanding its generic pharmaceutical portfol…