Clorazepate Dipotassium

ANDA 71780, held by Able. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 71780 (Clorazepate Dipotassium), held by Able, was first approved by FDA on Jun 26, 1987, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 26, 1987
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 26, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clorazepate Dipotassium3.75MG · tablet;oral	Clorazepate Dipotassium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 2, 2004	Supplement 8Labeling	Approved	None posted
Mar 28, 2001	Supplement 7Manufacturing	Approved	None posted
Aug 15, 1994	Supplement 6Labeling	Approved	None posted
Nov 25, 1992	Supplement 5Manufacturing	Approved	None posted
Aug 23, 1988	Supplement 4Manufacturing	Approved	None posted
Mar 10, 1988	Supplement 1Manufacturing	Approved	None posted
Mar 10, 1988	Supplement 2Labeling	Approved	None posted
Mar 10, 1988	Supplement 3Manufacturing	Approved	None posted
Jun 26, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71780
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