Regulatorische Updates

The FDA granted original approval for ANDA081189, a 25 mg oral Hydrochlorothiazide tablet from Watson Labs, with multiple labeling supplements approved through 1995. The product is now discontinued.

Mylan’s ANDA083528 for propoxyphene hydrochloride 32 mg oral capsules is listed as discontinued by the FDA.

TABLICAPS has filed ANDA084632 for an oral aminophylline 100 mg delayed‑release tablet, currently listed as discontinued.

FDA listed approval for ANDA078132 submitted by Northstar Healthcare covering oral ibuprofen tablets (400 mg, 600 mg, 800 mg) now marked discontinued.

FDA approved Hikma International Pharmaceutics' generic lithium carbonate 300 mg tablet (ANDA 078715) on Dec 28 2010, with a labeling supplement approved in 2012.

The FDA has approved ANDA079029 for oral amiodarone hydrochloride tablets (100 mg, 200 mg, 400 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.

FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.

FDA records indicate the FLUTEX topical ointment (0.1% Triamcinolone Acetoinide) by IVAX PHARMS is discontinued, with original ANDA approval in 1988 and a labeling supplement in 1992.

FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.

The FDA approved ANDA 085208 for a 50 mg oral tablet of hydrochlorothiazide, now marked as discontinued, with supplemental manufacturing and labeling approvals spanning 1981‑2020.

The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.

The FDA has approved Teva Pharmaceuticals’ oral capsule generic of chlordiazepoxide hydrochloride under ANDA 084768, with multiple supplemental manufacturing and labeling approvals.