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FDA · 22,614 results Live
FDA Dr. Mar 16 — 0.00

FDA Approves ELTROMBOPAG — Dr. Reddy's Laboratories Inc.,

Dr. Reddy’s Laboratories Inc. announced the FDA approval of its oral Eltrombopag Olamine (ANDA219121), which is slated for March 16, 2026, and positions the company to capture mark…

FDA Aurobindo Mar 13 — 0.00

FDA Approves CITALOPRAM — Aurobindo Pharma Limited

# FDA Approves Generic Citalopram for Aurobindo Pharma Aurobindo Pharma Limited has received FDA approval for its generic citalopram hydrobromide oral formulation (ANDA219985), en…

FDA HETERO Mar 12 — 0.00

FDA Approves Unknown Drug — HETERO LABS LTD III

# FDA Approves Generic Drug Application for Hetero Labs Hetero Labs Ltd III received FDA approval for an abbreviated new drug application (ANDA218264) on March 12, 2026, positioni…

FDA Biocon Mar 11 — 0.00

FDA Approves LIRAGLUTIDE — Biocon Pharma Inc.

# FDA Approves Generic Liraglutide from Biocon Pharma Inc. Biocon Pharma Inc. has received FDA approval for its generic formulation of liraglutide (ANDA215245), a widely-prescribe…

FDA Zydus Mar 11 — 0.00

FDA Approves CEVIMELINE HYDROCHLORIDE — Zydus Lifesciences Limited

# FDA Approves Zydus Lifesciences' Generic Cevimeline Hydrochloride Zydus Lifesciences Limited has received FDA approval for its generic cevimeline hydrochloride oral formulation,…

FDA DIFGEN Mar 10 — 0.00

FDA Approves Unknown Drug — DIFGEN PHARMS

# FDA Approves DIFGEN Pharms Generic Drug Application DIFGEN Pharms has received FDA approval for its abbreviated new drug application (ANDA 219997), potentially expanding the com…

FDA YICHANG Mar 10 — 0.00

FDA Approves Unknown Drug — YICHANG HUMANWELL

The FDA has granted approval to YICHANG HUMANWELL for a new Abbreviated New Drug Application, extending the company’s commercial footprint in the generic sector and supporting ongo…

FDA E5 Mar 9 — 0.00

FDA Approves Unknown Drug — E5 PHARMA

# FDA Approves E5 Pharma ANDA Application E5 Pharma has received FDA approval for ANDA216808, marking a significant expansion of the company's generic drug portfolio and positioni…

FDA KNACK Mar 9 — 0.00

FDA Approves Unknown Drug — KNACK

# FDA Approves KNACK's Generic Drug Application KNACK has received FDA approval for its abbreviated new drug application (ANDA 218675), positioning the company to capture market s…

FDA STERANCO Mar 9 — 0.00

FDA Approves Unknown Drug — STERANCO HLTHCARE

# FDA Approves ANDA for Steranco Healthcare Steranco Healthcare has received FDA approval for an abbreviated new drug application (ANDA220281), positioning the company to expand i…

FDA CONTRACT Mar 9 — 0.00

FDA Approves Unknown Drug — CONTRACT PHARMACAL

CONTRACT PHARMACAL today announced that the FDA has granted approval for its ANDA #219603, a milestone likely to boost the company's generic revenue streams as it prepares for the …

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 …