Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories
FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)
The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Oxford Generic Amlodipine Besylate Tablets (ANDA078414)
FDA granted approval for ANDA078414, authorizing Oxford Pharmaceuticals' generic amlodipine besylate tablets in 2.5 mg, 5 mg, and 10 mg strengths.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA090353 for Senores Pharms Topiramate Tablets (Discontinued)
Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA090007 for Generic Gabapentin Capsules
FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Lannett’s VELTANE 4 mg Oral Tablet (ANDA 084088)
The FDA has granted approval for Lannett’s generic VELTANE oral tablet containing 4 mg brompheniramine maleate (ANDA 084088).
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 076507 for Fluconazole Tablets
FDA has approved ANDA 076507 submitted by TARO for oral Fluconazole tablets in 50‑200 mg strengths; all listed products are marked discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Hikma Phenytoin Sodium Injection (ANDA 084307)
FDA has approved ANDA 084307 for Hikma Pharmaceuticals' generic phenytoin sodium injectable, available for intramuscular and intravenous use with multiple NDC listings.
Regulatory Updates
Sep 15, 2026•1 min read
Sandoz Receives FDA Tentative Approval for Epinastine Hydrochloride Ophthalmic Solution (ANDA090950)
Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva's Chlordiazepoxide Hydrochloride Generic (ANDA 084769)
The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Reserpine and Hydroflumethiazide Tablet (ANDA 088932)
The FDA granted approval (AP) for ANDA 088932 submitted by IVAX PHARMS for an oral tablet containing 0.125 mg reserpine and 50 mg hydroflumethiazide; the product is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA078598 for Ciprofloxacin Hydrochloride Ophthalmic Solution
The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.