Clorazepate Dipotassium

ANDA 71511, held by Natco Pharma USA. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 71511 (Clorazepate Dipotassium), held by Natco Pharma USA, was first approved by FDA on Oct 19, 1987, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 19, 1987
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 19, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clorazepate Dipotassium15MG · capsule;oral	Clorazepate Dipotassium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 21, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Aug 21, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Oct 19, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71511
Drugs@FDA: Overview at FDA
Company: Natco Pharma USA

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