FDA Approves Nitrofurazone Topical Solution (ANDA087081)

The U.S. Food and Drug Administration has granted approval for ANDA087081, an abbreviated new drug application for a nitrofurazone 0.2% topical solution. The product, submitted by sponsor Wendt, is classified as a TOPICAL route and comes in a SOLUTION dosage form. The submission was an original (ORIG) filing, submission number 1, and received an approved (AP) status on July 22, 1981. The product is currently marked as discontinued in the FDA records. Key details: - Brand name: Nitrofurazone - Strength: 0.2% - Route: Topical - Dosage form: Solution - Sponsor: Wendt - Application number: ANDA087081 - Submission status: Approved (AP) as of 1981-07-22 - Marketing status: Discontinued