規制動向

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#ciclopirox ×

2026年9月27日•1分で読めます

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.

2026年9月24日•1分で読めます

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.

2026年8月30日•1分で読めます

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.

2026年8月30日•1分で読めます

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.

2026年8月30日•1分で読めます

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.