Lorazepam

ANDA 71038, held by Warner Chilcott. Lorazepam.

As of Nov 13, 2026, ANDA 71038 (Lorazepam), held by Warner Chilcott, was first approved by FDA on Jan 12, 1988, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 12, 1988
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 12, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lorazepam1MG · tablet;oral	Lorazepam	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 12, 1990	Supplement 4Labeling	Approved	None posted
Jan 12, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71038
Drugs@FDA: Overview at FDA
Company: Warner Chilcott Company

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