Meprobamate

ANDA 84153, held by Acella. Meprobamate.

As of Nov 14, 2026, ANDA 84153 (Meprobamate), held by Acella, was first approved by FDA on Jul 3, 1974, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1974
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 3, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 26, 1989	Supplement 44Bioequivalence	Approved	None posted
Aug 4, 1983	Supplement 40Manufacturing	Approved	None posted
Aug 4, 1983	Supplement 39Manufacturing	Approved	None posted
Aug 4, 1983	Supplement 38Manufacturing	Approved	None posted
Jul 3, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84153
Drugs@FDA: Overview at FDA
Company: Acella Pharmaceuticals

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