The U.S. Food and Drug Administration has approved application ANDA080699 submitted by SUN PHARM INDUSTRIES for the generic drug Meprobamate, an oral tablet.
The ANDA lists two tablet strengths: 200 mg (product number 001) and 400 mg (product number 002). Both products are currently marked as discontinued.
Approval history includes several manufacturing (CMC) submissions (numbers 118, 123, 124, 125, 126, 128, 129, 130) and labeling submissions (numbers 121, 122). These were approved on dates ranging from March 12, 1986 to December 1, 1998. The original ANDA filing date was October 16, 1972.
規制動向2026年8月25日•1分で読めます
FDA Approves ANDA080699 for Meprobamate Oral Tablets
The FDA granted approval for SUN PHARM INDUSTRIES' ANDA080699 covering oral Meprobamate tablets (200 mg and 400 mg). Multiple manufacturing and labeling submissions were approved between 1986 and 1998; the products are now discontinued.
PharmaCountryチームがまとめました · 出典： FDA.gov
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