Regulatory Updates
Sep 28, 2026•1 min read
FDA Discontinues Hydrocortisone 0.5% Ointment (ANDA084969)
The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA217117 for LIDOCAINE Topical Ointment
The FDA has approved Aurobindo Pharma's LIDOCAINE 5% topical ointment (ANDA217117) for prescription use, with a standard review completed on June 18, 2024.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Mometasone Furoate Topical Ointment (ANDA076481)
FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.
Regulatory Updates
Sep 15, 2026•1 min read
Glenmark Pharm's Mometasone Furoate Ointment (ANDA078571) Receives Multiple Labeling Approvals
The FDA approved the original ANDA for Glenmark's Mometasone Furoate topical ointment on May 28, 2008, and later granted labeling supplements in 2015 and 2024; the product is now discontinued.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves Padagis Israel’s Desoximetasone 0.25% Topical Ointment (ANDA077770)
The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.