Diazepam

ANDA 70227, held by Dava Pharms Inc. Diazepam.

As of Nov 13, 2026, ANDA 70227 (Diazepam), held by Dava Pharms Inc, was first approved by FDA on Sep 26, 1985, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 26, 1985
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 26, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam5MG · tablet;oral	Diazepam	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 5, 1997	Supplement 14Manufacturing	Approved	None posted
Nov 19, 1997	Supplement 13Manufacturing	Approved	None posted
Nov 19, 1997	Supplement 12Manufacturing	Approved	None posted
Nov 19, 1997	Supplement 11Labeling	Approved	None posted
Aug 25, 1994	Supplement 9Labeling	Approved	None posted
May 19, 1989	Supplement 8Labeling	Approved	None posted
Jun 14, 1988	Supplement 7Labeling	Approved	None posted
Nov 17, 1987	Supplement 6Manufacturing	Approved	None posted
Aug 26, 1987	Supplement 5Manufacturing	Approved	None posted
Aug 26, 1987	Supplement 4Manufacturing	Approved	None posted
Sep 26, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70227
Drugs@FDA: Overview at FDA
Company: DAVA Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters