Clorazepate Dipotassium

ANDA 71744, held by Dava Pharms Inc. Clorazepate Dipotassium.

As of Nov 15, 2026, ANDA 71744 (Clorazepate Dipotassium), held by Dava Pharms Inc, was first approved by FDA on Dec 14, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1987
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
Dec 14, 1987	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jul 2, 1993	Supplement 2Labeling	Approved	None posted
Sep 8, 1989	Supplement 1Labeling	Approved	None posted
Dec 14, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71744
Drugs@FDA: Overview at FDA
Company: DAVA Pharmaceuticals

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