Regulatory UpdatesSep 22, 2026•1 min read

FDA Discontinues Chlordiazepoxide Hydrochloride ANDA084700

By the PharmaCountry team

The FDA has listed the ANDA084700 application for Chlordiazepoxide Hydrochloride 10 mg oral capsules as discontinued. Sponsor Roxane filed the original ANDA in 1976.

The FDA has marked the ANDA084700 application for Chlordiazepoxide Hydrochloride as discontinued. The product was an oral capsule containing 10 mg of Chlordiazepoxide Hydrochloride, identified by product number 001, and its marketing status is now discontinued. The original ANDA (submission 1) received approval on July 2, 1976, and a supplemental manufacturing (CMC) submission (submission 11) was approved on January 3, 1983. The sponsor of the application is Roxane.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ANDA #chlordiazepoxide #FDA #discontinuation #Oral Capsules #Roxane