Regulatory UpdatesAug 30, 2026•1 min read

Epic Pharma LLC Submits ANDA078975 for Topical Ciclopirox 8% Solution (Discontinued)

By the PharmaCountry team

Epic Pharma LLC filed ANDA078975 for a discontinued topical ciclopirox 8% solution; FDA records show the original submission was approved on 2010-02-17.

Epic Pharma LLC has filed an Abbreviated New Drug Application (ANDA) identified as ANDA078975 for a topical ciclopirox 8% solution. The product, listed under the brand name CICLOPIROX, is a discontinued topical solution. The submission is classified as an original (ORIG) application, with a submission status of approved (AP) dated February 17, 2010. No reference drug or reference standard is indicated.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ciclopirox #topical #ANDA #generic #discontinued #Epic Pharma