Meprobamate

As of Nov 13, 2026, NDA 14547 (Meprobamate), held by Sandoz, was first approved by FDA on Jul 26, 1963, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1963
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 26, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued
Meprobamate200MG · tablet;oral	Meprobamate	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 18, 2001	Supplement 16Labeling · Standard review	Approved	None posted
Nov 1, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 16, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 9, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 18, 1986	Supplement 6Labeling	Approved	None posted
Feb 10, 1981	Supplement 3Labeling	Approved	None posted
Jul 26, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 14547
Drugs@FDA: Overview at FDA
Company: Sandoz

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