Meprobamate

ANDA 80655, held by Rising. Meprobamate.

As of Nov 14, 2026, ANDA 80655 (Meprobamate), held by Rising, was first approved by FDA on Jul 12, 1972, with 19 approved supplements and 0 published complete response letters.

First approved: Jul 12, 1972
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 12, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued

All 20 submissions, including labeling and manufacturing supplements


May 5, 1997	Supplement 89Manufacturing	Approved	None posted
Feb 21, 1995	Supplement 88Manufacturing	Approved	None posted
Dec 22, 1989	Supplement 87Labeling	Approved	None posted
Oct 18, 1989	Supplement 86Labeling	Approved	None posted
Aug 4, 1989	Supplement 85Labeling	Approved	None posted
Mar 28, 1988	Supplement 84Labeling	Approved	None posted
Nov 30, 1983	Supplement 81Manufacturing	Approved	None posted
Aug 4, 1983	Supplement 80Manufacturing	Approved	None posted
Aug 4, 1983	Supplement 79Manufacturing	Approved	None posted
Oct 18, 1982	Supplement 78Manufacturing	Approved	None posted
Oct 18, 1982	Supplement 77Manufacturing	Approved	None posted
Oct 18, 1982	Supplement 76Manufacturing	Approved	None posted
May 24, 1982	Supplement 71Manufacturing	Approved	None posted
May 18, 1982	Supplement 75Manufacturing	Approved	None posted
May 18, 1982	Supplement 73Manufacturing	Approved	None posted
May 18, 1982	Supplement 69Manufacturing	Approved	None posted
May 18, 1982	Supplement 62Manufacturing	Approved	None posted
May 18, 1982	Supplement 61Manufacturing	Approved	None posted
May 18, 1982	Supplement 42Manufacturing	Approved	None posted
Jul 12, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80655
Drugs@FDA: Overview at FDA
Company: Rising 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