Regulatory Updates
Sep 9, 2026•1 min read
FOSPHENYTOIN SODIUM (ANDA078736) FDA Approval
FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA078442 for Alprazolam Extended-Release Tablets (Discontinued)
The FDA approved the original ANDA for Alprazolam extended‑release tablets (product numbers 001‑004) on Oct 15 2007, with a labeling supplement approved on Nov 29 2011. All four strengths (0.5 mg, 1 mg, 2 mg, 3 mg) are now listed as discontinued by sponsor PH Health.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Lupin Generic Levetiracetam Tablets (ANDA 078154)
The FDA has approved Lupin Pharmaceuticals’ generic levetiracetam tablets in 250 mg, 500 mg, and 750 mg oral strengths under ANDA 078154.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves FLUMAZENIL (ANDA076955) for Intravenous Use
The FDA has approved the injectable drug FLUMAZENIL (application ANDA076955) from Fresenius Kabi USA, available in two IV strengths.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA 076392 for Mefloquine Hydrochloride
The FDA has approved ANDA 076392 for Mefloquine Hydrochloride oral tablets (250 mg) manufactured by Teva Pharmaceuticals, sponsor BARR.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080807 for Diphenhydramine Capsules – IMPAX Labs
FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues Oral Solution PAMELOR (Nortriptyline Hydrochloride) – NDA 018012
The FDA records show PAMELOR oral solution (nortriptyline hydrochloride) is discontinued, with a history of labeling and manufacturing submissions from 1977 to 2014.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Sorbitol-Mannitol (NDA018316) for Urethral Irrigation
The FDA has approved the prescription drug Sorbitol-Mannitol (NDA018316), a urethral irrigation solution containing mannitol and sorbitol, manufactured by ICU Medical Inc.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA086088 for Hydralazine Hydrochloride Oral Tablet (Discontinued)
The FDA has listed ANDA086088 for Hydralazine Hydrochloride 25 mg oral tablets submitted by Vitarine, noting the product is discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues PROVAL #3 Oral Capsule (ANDA085685)
FDA records show PROVAL #3 oral capsule, containing 325 mg acetaminophen and 30 mg codeine phosphate, is now discontinued. Sponsor: Solvay. ANDA085685.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Lists Watson Labs' Meclizine Hydrochloride 12.5 mg Tablet (ANDA 085195) as Discontinued
The FDA’s ANDA 085195 for Watson Labs’ oral Meclizine Hydrochloride 12.5 mg tablet is marked discontinued, indicating the product is no longer marketed.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA084731 for Theophylline Oral Capsules (Discontinued)
The FDA has approved ANDA084731 for Theophylline capsules in 100 mg, 200 mg and 250 mg strengths. All three products are listed as discontinued by sponsor Scherer RP.