The U.S. Food and Drug Administration has granted approval for ANDA087129, covering an oral tablet of Cyproheptadine Hydrochloride (4 mg) marketed by Strides Pharma International. The product is listed as discontinued.
The submission record shows an original approval on 9 July 1981, followed by multiple manufacturing (CMC) and labeling supplements spanning 1983 to 2002, with the most recent labeling supplement approved on 29 August 2002.
The product is identified as route oral, dosage form tablet, product number 001, and is not a reference drug.
Regulatorische Updates15. Sept. 2026•3 Min. Lesezeit
FDA Approves ANDA087129 for Cyproheptadine Hydrochloride Tablet
FDA has approved ANDA087129 for a 4 mg oral tablet of Cyproheptadine Hydrochloride, sponsored by Strides Pharma Intl, with a history of labeling and manufacturing supplements.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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