Meprobamate

ANDA 89538, held by Lee Km. Meprobamate.

As of Nov 14, 2026, ANDA 89538 (Meprobamate), held by Lee Km, was first approved by FDA on Nov 25, 1987, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 25, 1987
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
Nov 25, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 4, 1989	Supplement 2Labeling	Approved	None posted
Nov 25, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89538
Drugs@FDA: Overview at FDA
Company: Lee KM

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