Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling for PLASMA‑LYTE 56 and Dextrose 5% Injection (NDA 017385)
The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA078541 for Mometasone Furoate Cream
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Lupin Losartan Potassium/Hydrochlorothiazide Combination (ANDA078245)
FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA084581 for Hydralazine Tablet – IVAX Sub Teva
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Issues ANDA084080 for Promethazine Hydrochloride Tablet
FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
South Korea may delay convenience‑store OTC medicine expansion pending compliance review
The health ministry says expansion of safe OTC items in convenience stores could be postponed if illegal or improper sales practices are not corrected.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081069 for Hydrocodeine Bitartrate and Acetaminophen Oral Capsule
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA080482 for C & M Pharma’s Hydrocortisone Creams (Discontinued)
The FDA granted approval (ANDA080482) to C & M Pharma for two topical hydrocortisone cream products, both now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA083442 for Meprobamate 400mg Oral Tablet
The FDA approved ANDA083442 for a 400 mg oral tablet of meprobamate submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Primaquine Phosphate (NDA008316)
The FDA has approved Primaquine Phosphate, an oral prescription tablet (NDA008316) from Sanofi‑Aventis U.S. LLC, with recent labeling updates in 2025.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA088262 for Imipramine Hydrochloride Tablets by Strides Pharma
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.
Regulatory Updates
Sep 19, 2026•1 min read
PharmaFair Submits ANDA087922 for Discontinued Triamcinolone Acetone Topical Cream
FDA records show PharmaFair's ANDA087922 for a discontinued 0.5% Triamcinolone Acetone topical cream, not a reference drug.