The U.S. Food and Drug Administration has granted approval for Abbreviated New Drug Application (ANDA) number ANDA076788 submitted by Sun Pharma Canada. The application pertains to a topical lotion formulation containing Mometasone Furoate at a strength of 0.1%.
The product is recorded with a marketing status of “Discontinued.” The submission record shows an original approval on March 15, 2006, followed by two labeling supplement approvals (submission numbers 7 and 10) on March 2, 2015, and March 22, 2019, respectively.
No reference drug was cited for this product, and it is not designated as a reference standard. Both labeling supplements are classified under the FDA’s “Labeling” submission class code.
Regulatorische Updates15. Sept. 2026•3 Min. Lesezeit
FDA Approves Sun Pharma Canada ANDA for Mometasone Furoate Topical Lotion
FDA approved ANDA076788 for a Mometasone Furoate 0.1% topical lotion by Sun Pharma Canada; the product is listed as discontinued, with labeling supplements approved in 2015 and 2019.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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