Meprobamate

ANDA 85721, held by Watson Labs. Meprobamate.

As of Nov 14, 2026, ANDA 85721 (Meprobamate), held by Watson Labs, was first approved by FDA on Jul 13, 1977, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1977
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 13, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Apr 20, 1999	Supplement 33Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 32Manufacturing	Approved	None posted
Jul 18, 1997	Supplement 31Manufacturing	Approved	None posted
Jul 18, 1997	Supplement 30Manufacturing	Approved	None posted
Jul 18, 1997	Supplement 29Manufacturing	Approved	None posted
Apr 22, 1991	Supplement 28Labeling	Approved	None posted
Feb 2, 1989	Supplement 27Manufacturing	Approved	None posted
Feb 2, 1989	Supplement 25Manufacturing	Approved	None posted
Apr 14, 1988	Supplement 24Labeling	Approved	None posted
Dec 24, 1987	Supplement 22Manufacturing	Approved	None posted
Jul 21, 1987	Supplement 21Manufacturing	Approved	None posted
Jul 21, 1987	Supplement 20Manufacturing	Approved	None posted
Dec 10, 1986	Supplement 18Manufacturing	Approved	None posted
Jan 18, 1983	Supplement 14Manufacturing	Approved	None posted
Jul 13, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85721
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