Diazepam

ANDA 70904, held by Ferndale Labs. Diazepam.

As of Nov 13, 2026, ANDA 70904 (Diazepam), held by Ferndale Labs, was first approved by FDA on Apr 1, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 1, 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
Apr 1, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam5MG · tablet;oral	Diazepam	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 23, 1989	Supplement 3Labeling	Approved	None posted
May 11, 1988	Supplement 5Labeling	Approved	None posted
Apr 1, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70904
Drugs@FDA: Overview at FDA
Company: Ferndale Laboratories

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