Aurobindo Receives FDA Approval for Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg
Published: September 14, 2023
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg. Aurobindo Pharma’s Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Librax® Capsules manufactured by Bausch Health US, LLC.
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are indicated:
- To control emotional and somatic factors in gastrointestinal disorders
- Adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.