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.
法规动态2026年9月15日•3 分钟阅读
FDA Grants ANDA Approval for Mometasone Furoate Topical Lotion (ANDA077678)
The FDA approved an ANDA (ANDA077678) for a 0.1% mometasone furoate topical lotion submitted by Cosette Pharms NC; the product is listed as discontinued.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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