Clorazepate Dipotassium

ANDA 72220, held by Aurolife Pharma LLC. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 72220 (Clorazepate Dipotassium), held by Aurolife Pharma LLC, was first approved by FDA on Aug 26, 1988, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1988
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 26, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clorazepate Dipotassium7.5MG · capsule;oral	Clorazepate Dipotassium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Aug 24, 1999	Supplement 4Labeling	Approved	None posted
Sep 5, 1990	Supplement 1Labeling	Approved	None posted
Aug 26, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72220
Drugs@FDA: Overview at FDA
Company: Aurolife 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