Meprobamate

NDA 14882, held by Chartwell Molecular. Meprobamate.

As of Nov 13, 2026, NDA 14882 (Meprobamate), held by Chartwell Molecular, was first approved by FDA on Aug 9, 1963, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 9, 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
Aug 9, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Meprobamate400MG · tablet;oral	Meprobamate	Discontinued
Meprobamate200MG · tablet;oral	Meprobamate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Aug 22, 1986	Supplement 11Labeling	Approved	None posted
Sep 22, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 24, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 25, 1978	Supplement 7Labeling	Approved	None posted
Sep 8, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 8, 1977	Supplement 5Labeling	Approved	None posted
Aug 9, 1963	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 14882
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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