Meprobamate

ANDA 85720, held by Watson Labs. Meprobamate.

As of Nov 14, 2026, ANDA 85720 (Meprobamate), held by Watson Labs, was first approved by FDA on Jul 13, 1977, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1977
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate200MG · tablet;oral	Meprobamate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Aug 20, 1999	Supplement 31Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 30Manufacturing	Approved	None posted
Jul 18, 1997	Supplement 28Manufacturing	Approved	None posted
Jul 18, 1997	Supplement 29Manufacturing	Approved	None posted
Mar 26, 1997	Supplement 27Manufacturing	Approved	None posted
Apr 22, 1991	Supplement 26Labeling	Approved	None posted
Mar 28, 1988	Supplement 22Labeling	Approved	None posted
Dec 24, 1987	Supplement 20Manufacturing	Approved	None posted
Jul 21, 1987	Supplement 18Manufacturing	Approved	None posted
Jul 21, 1987	Supplement 19Manufacturing	Approved	None posted
Dec 10, 1986	Supplement 16Manufacturing	Approved	None posted
Dec 7, 1981	Supplement 7Manufacturing	Approved	None posted
Jul 13, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85720
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