The U.S. Food and Drug Administration has granted approval for ANDA 084769, a generic version of chlordiazepoxide hydrochloride manufactured by Teva Pharmaceuticals USA, Inc.
The product is an oral capsule marketed as a prescription drug, containing 25 mg of chlordiazepoxide hydrochloride. It is listed under several National Drug Code (NDC) identifiers, including 0555-0158-02, 0555-0158-04, 0555-0033-02, 0555-0033-05, 0555-0159-02, and 0555-0159-04.
Approval follows a series of supplemental submissions covering manufacturing (CMC) and labeling. Submission numbers include 47, 69, 71, 73, 77, 79, 81, 83, 85, and 87, with status dates ranging from 1982 to 2000.
The generic is designated as a reference drug and will be available for prescription use in the United States.
Regulatory UpdatesSep 15, 2026•3 min read
FDA Approves Teva's Chlordiazepoxide Hydrochloride Generic (ANDA 084769)
The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.
Compiled by the Pharmacountry team · Source: FDA.gov
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