Meprobamate

ANDA 83308, held by Watson Labs. Meprobamate.

As of Nov 14, 2026, ANDA 83308 (Meprobamate), held by Watson Labs, was first approved by FDA on May 3, 1973, with 14 approved supplements and 0 published complete response letters.

First approved: May 3, 1973
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
May 3, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Nov 22, 2004	Supplement 51Labeling	Approved	None posted
Apr 25, 2001	Supplement 49Manufacturing	Approved	None posted
Jan 20, 1998	Supplement 46Manufacturing	Approved	None posted
Jan 20, 1998	Supplement 47Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 43Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 44Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 42Manufacturing	Approved	None posted
Feb 8, 1989	Supplement 41Labeling	Approved	None posted
Oct 21, 1988	Supplement 38Manufacturing	Approved	None posted
Oct 21, 1988	Supplement 39Manufacturing	Approved	None posted
Oct 13, 1988	Supplement 40Labeling	Approved	None posted
Oct 13, 1988	Supplement 66Labeling	Approved	None posted
Jun 2, 1982	Supplement 35Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 36Manufacturing	Approved	None posted
May 3, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83308
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