Aurobindo
FDA Approves PIRFENIDONE — Aurobindo Pharma Limited
# FDA Approves Generic Pirfenidone from Aurobindo Pharma The FDA has approved Aurobindo Pharma Limited's generic version of pirfenidone, an oral anti...
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AUROBINDO
FDA Approves Unknown Drug — AUROBINDO PHARMA LTD
# FDA Approves Aurobindo Pharma Generic Drug Application Aurobindo Pharma Ltd has received FDA approval for its abbreviated new drug application (AND...
EXTROVIS
FDA Approves Unknown Drug — EXTROVIS
EXTROVIS announced the FDA approval of its ANDA application, a regulatory milestone expected to broaden its commercial portfolio and facilitate market...
MANKIND
FDA Approves Unknown Drug — MANKIND PHARMA
# FDA Approves Mankind Pharma Generic Drug Application Mankind Pharma has received FDA approval for its abbreviated new drug application (ANDA220398)...
Teva
FDA Approves GLYCEROL PHENYLBUTYRATE — Teva Pharmaceuticals, Inc.
# FDA Approves Teva's Generic Glycerol Phenylbutyrate Teva Pharmaceuticals has received FDA approval for its generic formulation of glycerol phenylbu...
Edenbridge
FDA Approves ATROPINE SULFATE — Edenbridge Pharmaceuticals LLC.
# FDA Approves Edenbridge Pharmaceuticals' Generic Atropine Sulfate Ophthalmic Formulation Edenbridge Pharmaceuticals LLC has received FDA approval f...
Alembic
FDA Approves METHOTREXATE — Alembic Pharmaceuticals Inc.
# FDA Approves Alembic Pharmaceuticals' Generic Methotrexate Sodium Injection Alembic Pharmaceuticals Inc. has received FDA approval for its generic ...
Novadoz
FDA Approves GLYCEROL PHENYLBUTYRATE — Novadoz Pharmaceuticals LLC
# FDA Approves Novadoz Pharmaceuticals' Generic Glycerol Phenylbutyrate Oral Formulation Novadoz Pharmaceuticals LLC has received FDA approval for it...
Baxter
FDA Approves DEXMEDETOMIDINE HYDROCHLORIDE — Baxter Healthcare Corporation
Baxter Healthcare Corporation received FDA approval for its intravenous generic dexmedetomidine, a move expected to drive immediate price competition ...
APOTEX
FDA Approves Unknown Drug — APOTEX
The FDA has approved the generic drug application (ANDA 210449) for Apotex, authorizing the manufacturer to launch a cost-effective alternative to the...
ANI
FDA Approves PIMOZIDE — ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc. announced the receipt of FDA approval for its pimozide ANDA, granting the company access to the established antipsychotic ma...
MICRO
FDA Approves Unknown Drug — MICRO LABS
MICRO LABS has secured FDA approval for a generic substance pursuant to ANDA206371, a milestone expected to bolster the company's market share and exp...
Aucta
FDA Approves FOSFOMYCIN TROMETHAMINE — Aucta Pharmaceuticals, Inc.
# FDA Approves Generic Fosfomycin Tromethamine, Expanding Treatment Options for Urinary Tract Infections Aucta Pharmaceuticals, Inc. received FDA app...
Apotex
FDA Approves MULTIPLE VITAMINS (ADULT) PHARMACY BULK PACKAGE — Apotex Corp.
Apotex Corp. has secured FDA approval for its Intravenous Adult Multiple Vitamins pharmacy bulk package, bolstering its commercial portfolio and provi...
Apotex
FDA Approves MULTIPLE VITAMINS (ADULT) SINGLE DOSE — Apotex Corp
On April 9, 2026, Apotex Corp received FDA approval for a generic Adult Multiple Vitamins single-dose product, a move likely to intensify price compet...
MICRO
FDA Approves Unknown Drug — MICRO LABS
# FDA Approves Micro Labs' Generic Drug Application Micro Labs has received FDA approval for its abbreviated new drug application (ANDA218557), expan...
Hikma
FDA Approves ELTROMBOPAG — Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. received FDA approval for its Abbreviated New Drug Application (ANDA) covering oral Eltrombopag Olamine on April 8, 202...
Glenmark
FDA Approves PROGESTERONE VAGINAL INSERTS — Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals USA announced today the approval of its generic progesterone vaginal inserts (ANDA 216363) by the FDA, a critical move to cap...
Ajanta
FDA Approves IVERMECTIN — Ajanta Pharma USA Inc.
# FDA Approves Generic Ivermectin ANDA from Ajanta Pharma USA Inc. Ajanta Pharma USA Inc. has received FDA approval for its generic ivermectin oral f...
Creekwood
FDA Approves NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — Creekwood Pharmaceuticals LLC
# FDA Approves Creekwood Pharmaceuticals' Generic Nitrofurantoin for Urinary Tract Infections The FDA has approved Creekwood Pharmaceuticals LLC's ge...