Regulatory Updates
Sep 27, 2026•1 min read
FDA NDA018363: HEXASCRUB Topical Sponge Discontinued
The FDA lists HEXASCRUB, a 3% hexachlorophene topical sponge, under application NDA018363 with a discontinued marketing status. Sponsor: PROF DSPLS.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA 078567 for Mylan’s Ciclopirox 8% Topical Solution
The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves AMMONIUM LACTATE Topical Lotion (ANDA 076216)
The FDA has approved a prescription topical lotion containing 12% ammonium lactate, submitted under ANDA 076216 by Sun Pharma Canada.
Regulatory Updates
Sep 25, 2026•1 min read
FDA ANDA088048 Approval for Fluocinolone Acetonide Topical Solution (Discontinued)
The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Labeling Updates for Alvogen’s Topical CICLOPIROX Gel (NDA020519)
Alvogen’s discontinued topical gel CICLOPIROX (0.77%) received FDA labeling submissions in 2013, with earlier filings dating back to 1997.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves ANDA087315 for Hydrocortisone 1% Topical Lotion
The FDA has approved ANDA087315 submitted by Alpharma US Pharms for a 1% hydrocortisone topical lotion, currently listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 078338 for Clotrimazole 1% Topical Cream
The FDA has approved ANDA 078338 for a prescription 1% clotrimazole topical cream marketed by Fougera Pharmas.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Nitrofurazone Topical Solution (ANDA087081)
The FDA approved ANDA087081 for a 0.2% nitrofurazone topical solution submitted by Wendt; the product is listed as discontinued.
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 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 Discontinues UTICORT Topical Lotion (NDA017528)
The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Triamcinolone Acetoinide 0.1% Cream (ANDA 088095)
The FDA has listed the topical Triamcinolone Acetoinide 0.1% cream, sponsored by Morton Grove, as discontinued under ANDA 088095.