Meprobamate

ANDA 83304, held by Watson Labs. Meprobamate.

As of Nov 14, 2026, ANDA 83304 (Meprobamate), held by Watson Labs, was first approved by FDA on Apr 23, 1973, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 23, 1973
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
Apr 23, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate200MG · tablet;oral	Meprobamate	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Nov 22, 2004	Supplement 43Labeling	Approved	None posted
Apr 25, 2001	Supplement 41Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 39Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 37Manufacturing	Approved	None posted
Feb 8, 1989	Supplement 36Labeling	Approved	None posted
Oct 25, 1988	Supplement 35Labeling	Approved	None posted
Oct 25, 1988	Supplement 58Labeling	Approved	None posted
Sep 23, 1988	Supplement 33Manufacturing	Approved	None posted
Sep 23, 1988	Supplement 34Manufacturing	Approved	None posted
Dec 12, 1985	Supplement 31Manufacturing	Approved	None posted
May 14, 1985	Supplement 29Manufacturing	Approved	None posted
May 14, 1985	Supplement 30Manufacturing	Approved	None posted
Apr 23, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83304
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