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.
規制動向2026年9月15日•3分で読めます
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.
Pharmacountryチームがまとめました · 出典： FDA.gov
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