Glenmark Pharm submitted an Abbreviated New Drug Application (ANDA) for a topical ointment containing 0.1% Mometasone Furoate. The product is not a reference drug and is currently listed as discontinued.
The original ANDA (submission number 1) received approval on May 28, 2008 (submission status: AP).
Subsequent supplemental submissions for labeling were approved on July 18, 2015 (submission number 7) and on August 14, 2024 (submission numbers 9 and 10), all with standard review priority.
No further changes to the product’s active ingredient or dosage form were reported beyond the labeling updates.
Regulatorische Updates15. Sept. 2026•3 Min. Lesezeit
Glenmark Pharm's Mometasone Furoate Ointment (ANDA078571) Receives Multiple Labeling Approvals
The FDA approved the original ANDA for Glenmark's Mometasone Furoate topical ointment on May 28, 2008, and later granted labeling supplements in 2015 and 2024; the product is now discontinued.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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