Clorazepate Dipotassium

ANDA 76911, held by Sun Pharm Inds Ltd. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 76911 (Clorazepate Dipotassium), held by Sun Pharm Inds Ltd, was first approved by FDA on Sep 29, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2004
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 29, 2004	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 30, 2010	Supplement 5Labeling	Approved	None posted
Aug 5, 2009	Supplement 4Labeling	Approved	None posted
Sep 29, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76911
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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