FDA approves ANDA 078079 for ciclopirox 8% topical solution

The U.S. Food and Drug Administration (FDA) released a letter on September 25, 2007 confirming approval of application number ANDA078079. The submission was made by Teva Pharms and pertains to a topical solution containing 8% ciclopirox. The product is identified as discontinued in the FDA’s records. The approval status (AP) was dated September 18, 2007. The official approval letter is available at the FDA’s website. Key details: - Sponsor: Teva Pharms - Product: Ciclopirox 8% topical solution (discontinued) - Application type: Original (ORIG) - Submission number: 1 - Approval status: AP (approved) - Reference: FDA approval letter (http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078079s000ltr.pdf)