Clorazepate Dipotassium

Manages anxiety disorders. ANDA 71858, held by Aurobindo Pharma. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 71858 (Clorazepate Dipotassium), held by Aurobindo Pharma, was first approved by FDA on Jul 17, 1987, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 17, 1987
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jul 17, 1987	Original application	Approved	None posted

Products

3 strengths and forms


Clorazepate Dipotassium15MG · tablet;oral	Clorazepate Dipotassium	Rx
Clorazepate Dipotassium3.75MG · tablet;oral	Clorazepate Dipotassium	Rx
Clorazepate Dipotassium7.5MG · tablet;oral	Clorazepate Dipotassium	Rx

All 13 submissions, including labeling and manufacturing supplements


Oct 27, 2010	Supplement 20Labeling	Approved	None posted
Jan 14, 2010	Supplement 19Labeling	Approved	None posted
Dec 2, 2004	Supplement 14Labeling	Approved	None posted
Dec 1, 2003	Supplement 13Labeling	Approved	None posted
Feb 25, 1998	Supplement 11Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 10Manufacturing	Approved	None posted
Aug 11, 1993	Supplement 7Manufacturing	Approved	None posted
May 17, 1993	Supplement 8Labeling	Approved	None posted
Apr 5, 1991	Supplement 6Labeling	Approved	None posted
Jan 31, 1990	Supplement 5Manufacturing	Approved	None posted
Aug 13, 1987	Supplement 2Manufacturing	Approved	None posted
Aug 13, 1987	Supplement 1Manufacturing	Approved	None posted
Jul 17, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71858
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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