Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Alembic’s Tretinoin 0.05% Topical Cream (ANDA214590)
The FDA has granted approval for Alembic’s prescription tretinoin 0.05% cream, submitted under ANDA214590.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA076367 for Amcinonide Topical Ointment
FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Grants ANDA Approval for Mometasone Furoate Topical Lotion (ANDA077678)
The FDA approved an ANDA (ANDA077678) for a 0.1% mometasone furoate topical lotion submitted by Cosette Pharms NC; the product is listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sun Pharma Canada ANDA for Mometasone Furoate Topical Lotion
FDA approved ANDA076788 for a Mometasone Furoate 0.1% topical lotion by Sun Pharma Canada; the product is listed as discontinued, with labeling supplements approved in 2015 and 2019.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA089706 for Hydrocortisone 1% Cream – Discontinued
The FDA approved ANDA089706 for a topical hydrocortisone 1% cream submitted by NASKA. The product is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
Fougera Pharms Receives FDA Approval for CALCIPOTRIENE Topical Solution (ANDA 078305)
The FDA has approved Fougera Pharms' CALCIPOTRIENE 0.005% topical solution under ANDA 078305, a new prescription product.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NDA017421 for DIAL Topical Solution Containing 0.25% Hexachlorophene
The FDA granted approval (NDA017421) for DIAL’s discontinued topical solution containing 0.25% hexachlorophene.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves RETIN-A (Tretinoin) Topical Gel – NDA 017579
The FDA has approved NDA017579 for RETIN-A, a prescription 0.025% tretinoin topical gel marketed by Bausch Health US and Mylan Pharmaceuticals.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080693 for Hydrocortisone 1% Topical Cream
The FDA has approved application ANDA080693 for a prescription 1% hydrocortisone topical cream marketed as HYDROCORTISONE by Fougera Pharm Inc.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Discontinues FLUONID Topical Ointment (ANDA 087157)
The FDA lists the FLUONID ointment (0.025% fluocinonide) under ANDA 087157 as discontinued, sponsored by Allergan Herbert.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA209610 for Clindamycin Phosphate and Benzoyl Peroxide Gel
The FDA has approved ANDA209610 for a prescription topical gel combining clindamycin phosphate (EQ 1.2% base) and benzoyl peroxide (3.75%). The product is marketed by Padagis Israel Pharmaceuticals Ltd.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Multiple Submissions for CYCLOCORT Topical Cream (NDA018116)
The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.