The FDA’s Center for Drug Evaluation and Research granted approval for ANDA071510, submitted by Natco Pharma USA, for an oral capsule containing 7.5 mg of clorazepate dipotassium. The product, identified as product number 001, is currently listed with a marketing status of discontinued and is not designated as a reference drug.
The original ANDA submission (submission number 1) received approval on October 19, 1987. Subsequent supplemental submissions (numbers 2, 3, and 5) were approved for labeling changes on December 16, 2016, and August 21, 2025 (two approvals), respectively.
Regulatory UpdatesSep 17, 2026•3 min read
FDA Approves ANDA071510 for Clorazepate Dipotassium Oral Capsule
The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.
Compiled by the Pharmacountry team · Source: FDA.gov
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