Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Gemcitabine Injection (ANDA079183)
The FDA has approved the ANDA for gemcitabine injection (ANDA079183) from Hospira, Inc., with details on submission history and labeling updates.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Apotex Generic Tizanidine Hydrochloride Capsules (ANDA078868)
The FDA has approved Apotex’s generic Tizanidine Hydrochloride oral capsules (2 mg, 4 mg, 6 mg) under application ANDA078868.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Updates for Granisetron Injection (ANDA078564)
FDA has approved labeling supplements for ANDA078564, a discontinued Granisetron Hydrochloride injection product by Wockhardt USA, with submissions dated 2008, 2014, and 2015.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Multiple Risperidone Tablet Products under ANDA 078269
FDA has approved several oral risperidone tablet strengths ranging from 0.25 mg to 4 mg under ANDA 078269, with labeling submissions completed.
Regulatory Updates
Sep 19, 2026•1 min read
KV Pharma’s Quinine Sulfate Tablet (ANDA 085276) Marked Discontinued by FDA
The FDA’s ANDA085276 for KV Pharma’s oral quinine sulfate 200 mg tablet is listed as discontinued, indicating it is no longer marketed.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Trimethobenzamide Injection (ANDA 089094)
The FDA has listed the injectable Trimethobenzamide Hydrochloride (product 001) from sponsor SoloPak as discontinued under ANDA 089094.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 088734 for Meclizine Hydrochloride Tablet
FDA granted approval for ANDA 088734, an oral 25 mg Meclizine Hydrochloride tablet by PLIVA. The product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Triamcinolone Acetoinide 0.1% Cream (ANDA 088095)
The FDA has listed the topical Triamcinolone Acetoinide 0.1% cream, sponsored by Morton Grove, as discontinued under ANDA 088095.
Regulatory Updates
Sep 19, 2026•1 min read
Copley Pharm’s Amitriptyline Hydrochloride Tablet (ANDA 088423) Discontinued
The FDA lists Copley Pharm’s oral Amitriptyline Hydrochloride 50 mg tablet (product #001) under ANDA 088423 as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Dextrose 10% & Sodium Chloride 0.9% Injectable (Now Discontinued)
The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing Submissions for Discontinued Trimpex Trimethoprim Tablets
The FDA’s NDA 017952 record lists two discontinued oral Trimpex tablets (100 mg and 200 mg trimethoprim) and documents a series of approved manufacturing and labeling submissions spanning 1980‑1997.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Lists Prednisolone 5 mg Tablet (ANDA080236) from Valeant as Discontinued
The FDA database shows a prednisolone 5 mg oral tablet submitted under ANDA080236 by Valeant Pharmaceuticals International, currently marked as discontinued.