Clorazepate Dipotassium

ANDA 71779, held by Able. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 71779 (Clorazepate Dipotassium), held by Able, was first approved by FDA on Jul 14, 1987, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 14, 1987
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 14, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clorazepate Dipotassium15MG · capsule;oral	Clorazepate Dipotassium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 10, 1988	Supplement 2Labeling	Approved	None posted
Jul 14, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71779
Drugs@FDA: Overview at FDA
Company: Able 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