Diazepam

ANDA 70895, held by Duramed Pharms Barr. Diazepam.

As of Nov 14, 2026, ANDA 70895 (Diazepam), held by Duramed Pharms Barr, was first approved by FDA on Aug 27, 1986, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 27, 1986
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 27, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam5MG · tablet;oral	Diazepam	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 22, 1989	Supplement 5Labeling	Approved	None posted
Feb 17, 1989	Supplement 4Labeling	Approved	None posted
Aug 19, 1988	Supplement 3Labeling	Approved	None posted
Aug 27, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70895
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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