Chlordiazepoxide Hydrochloride

ANDA 84706, held by Roxane. Chlordiazepoxide Hydrochloride.

As of Nov 15, 2026, ANDA 84706 (Chlordiazepoxide Hydrochloride), held by Roxane, was first approved by FDA on Jul 2, 1976, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 2, 1976
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 2, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlordiazepoxide Hydrochloride5MG · capsule;oral	Chlordiazepoxide Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 3, 1983	Supplement 10Manufacturing	Approved	None posted
Jul 2, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84706
Drugs@FDA: Overview at FDA
Company: Roxane Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters