Miltown

ANDA 83919, held by Medpointe Pharm Hlc. Meprobamate.

As of Nov 14, 2026, ANDA 83919 (Miltown), held by Medpointe Pharm Hlc, was first approved by FDA on Jan 28, 1974, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 28, 1974
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 28, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miltown600MG · tablet;oral	Meprobamate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Dec 30, 1993	Supplement 15Manufacturing	Approved	None posted
Apr 5, 1990	Supplement 14Labeling	Approved	None posted
Mar 3, 1989	Supplement 13Manufacturing	Approved	None posted
May 9, 1983	Supplement 10Manufacturing	Approved	None posted
Jul 14, 1982	Supplement 8Manufacturing	Approved	None posted
Jan 28, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 83919
Drugs@FDA: Overview at FDA
Company: Medpointe 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