Meprobamate

ANDA 83830, held by Whiteworth Town Plsn. Meprobamate.

As of Nov 14, 2026, ANDA 83830 (Meprobamate), held by Whiteworth Town Plsn, was first approved by FDA on Feb 13, 1974, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 13, 1974
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 13, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate200MG · tablet;oral	Meprobamate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 20, 1987	Supplement 7Manufacturing	Approved	None posted
Feb 13, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 83830
Drugs@FDA: Overview at FDA
Company: Whiteworth Town Plsn

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