Clorazepate Dipotassium

ANDA 71852, held by Watson Labs. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 71852 (Clorazepate Dipotassium), held by Watson Labs, was first approved by FDA on Feb 9, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1988
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 9, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Feb 19, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Nov 23, 2004	Supplement 12Labeling	Approved	None posted
Dec 1, 2003	Supplement 11Labeling	Approved	None posted
Aug 31, 2001	Supplement 9Manufacturing	Approved	None posted
Oct 29, 1998	Supplement 8Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 7Labeling	Approved	None posted
Sep 9, 1992	Supplement 6Labeling	Approved	None posted
Feb 12, 1992	Supplement 5Labeling	Approved	None posted
Jun 22, 1990	Supplement 4Labeling	Approved	None posted
Dec 12, 1988	Supplement 1Manufacturing	Approved	None posted
Feb 9, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71852
Drugs@FDA: Overview at FDA
Company: Watson 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