法规动态

The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.

FDA approved application ANDA078541 for a 0.1% mometasone furoate topical cream by Glenmark Pharmaceuticals. Original approval in 2008 with later labeling updates; product now discontinued.

FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.

FDA approved ANDA084581 for a 100 mg oral tablet of Hydralazine Hydrochloride by IVAX Sub Teva Pharm on Sep 12 1975; the product is now discontinued.

FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.

The health ministry says expansion of safe OTC items in convenience stores could be postponed if illegal or improper sales practices are not corrected.

The FDA approved ANDA081069 for an oral capsule containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen, sponsored by Mikart. The product is listed as discontinued.

The FDA granted approval (ANDA080482) to C & M Pharma for two topical hydrocortisone cream products, both now listed as discontinued.

The FDA approved ANDA083442 for a 400 mg oral tablet of meprobamate submitted by Whiteworth Town Plsn; the product is listed as discontinued.

The FDA has approved Primaquine Phosphate, an oral prescription tablet (NDA008316) from Sanofi‑Aventis U.S. LLC, with recent labeling updates in 2025.

The FDA has approved the ANDA for Imipramine Hydrochloride 25 mg oral tablets (brand name IMIPRAMINE HYDROCHLORIDE) manufactured by Strides Pharma Science Limited, with the latest labeling approval on May 1 2023.

FDA records show PharmaFair's ANDA087922 for a discontinued 0.5% Triamcinolone Acetone topical cream, not a reference drug.