Lorazepam

ANDA 71087, held by Watson Labs. Lorazepam.

As of Nov 13, 2026, ANDA 71087 (Lorazepam), held by Watson Labs, was first approved by FDA on Mar 23, 1987, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 23, 1987
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 23, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lorazepam1MG · tablet;oral	Lorazepam	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 29, 1998	Supplement 6Manufacturing	Approved	None posted
Apr 5, 1995	Supplement 5Labeling	Approved	None posted
Mar 24, 1989	Supplement 4Labeling	Approved	None posted
Jun 22, 1987	Supplement 1Manufacturing	Approved	None posted
Mar 23, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71087
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