Oxazepam

ANDA 71494, held by Watson Labs. Oxazepam.

As of Nov 15, 2026, ANDA 71494 (Oxazepam), held by Watson Labs, was first approved by FDA on Apr 21, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 21, 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 21, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxazepam15MG · tablet;oral	Oxazepam	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 21, 1998	Supplement 6Labeling	Approved	None posted
Oct 19, 1993	Supplement 5Labeling	Approved	None posted
Apr 21, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71494
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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