Meprobamate

ANDA 80699, held by Sun Pharm Industries. Meprobamate.

As of Nov 14, 2026, ANDA 80699 (Meprobamate), held by Sun Pharm Industries, was first approved by FDA on Oct 16, 1972, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 16, 1972
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 16, 1972	Original application	Approved	None posted

Products

2 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 130Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 129Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 123Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 124Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 125Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 126Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 128Manufacturing	Approved	None posted
Mar 15, 1989	Supplement 122Labeling	Approved	None posted
Oct 13, 1988	Supplement 121Labeling	Approved	None posted
Mar 12, 1986	Supplement 118Manufacturing	Approved	None posted
Oct 16, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80699
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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