Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077248 for Pilocarpine Hydrochloride Oral Tablets
The FDA has granted approval for ANDA077248, an oral tablet formulation of pilocarpine hydrochloride (5 mg and 7.5 mg) manufactured by Impax Labs and Amneal Pharmaceuticals.
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 Watson Labs Ciprofloxacin Ophthalmic Solution (ANDA 076673)
FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.
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
Marshall Pharma Prednisone Tablet (5 mg) ANDA080301 Discontinued
FDA records indicate Marshall Pharma's oral prednisone 5 mg tablet (product 001) under application ANDA080301 is listed as discontinued.
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.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA090265 for Hydrocodone/Acetaminophen Tablets
The FDA's ANDA090265, submitted by CARACO, received approval on Dec 23, 2008 for three oral hydrocodone bitartrate/acetaminophen tablet strengths, now listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
CENCI Announces Discontinuation of PROMETHAZINE Oral Syrup (ANDA089013)
CENCI's PROMETHAZINE oral syrup (product 001) is listed as discontinued in the FDA ANDA089013 filing.