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 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
Aug 30, 2026•1 min read
FDA Approves ANDA078594 for Topical Ciclopirox Shampoo
The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.
Regulatory Updates
Aug 30, 2026•1 min read
Epic Pharma LLC Submits ANDA078975 for Topical Ciclopirox 8% Solution (Discontinued)
Epic Pharma LLC filed ANDA078975 for a discontinued topical ciclopirox 8% solution; FDA records show the original submission was approved on 2010-02-17.
Regulatory Updates
Aug 30, 2026•1 min read
FDA approves ANDA 078079 for ciclopirox 8% topical solution
FDA issued an approval letter on Sep 25, 2007 for Teva Pharms' ANDA 078079 covering a discontinued ciclopirox 8% topical solution.