Lorazepam

ANDA 70473, held by Mutual Pharm. Lorazepam.

As of Nov 13, 2026, ANDA 70473 (Lorazepam), held by Mutual Pharm, was first approved by FDA on Dec 10, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1985
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 10, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lorazepam1MG · tablet;oral	Lorazepam	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 1, 1998	Supplement 20Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 19Manufacturing	Approved	None posted
Sep 24, 1993	Supplement 18Labeling	Approved	None posted
Apr 3, 1992	Supplement 15Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 17Manufacturing	Approved	None posted
Mar 25, 1991	Supplement 13Bioequivalence	Approved	None posted
Mar 25, 1991	Supplement 14Bioequivalence	Approved	None posted
Oct 27, 1989	Supplement 4Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 9Manufacturing	Approved	None posted
Feb 4, 1987	Supplement 7Manufacturing	Approved	None posted
Dec 23, 1986	Supplement 1Manufacturing	Approved	None posted
Dec 10, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70473
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical 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