FDA Grants ANDA Approval for Mometasone Furoate Topical Lotion (ANDA077678)

The U.S. Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) identified as ANDA077678 for a topical mometasone furoate lotion. The product, marketed under the brand name Mometasone Furoate, is a 0.1% strength lotion intended for topical use. The sponsor listed is Cosette Pharms NC. FDA records indicate the product’s marketing status is listed as discontinued. The approval follows two submissions: an original submission (submission number 1) received on 21 November 2007 and a labeling supplement (submission number 8) received on 4 January 2021, both with an approved status. No reference drug or reference standard was cited for this application.