Methocarbamol

ANDA 85961, held by Clonmel Hlthcare. Methocarbamol.

As of Nov 14, 2026, ANDA 85961 (Methocarbamol), held by Clonmel Hlthcare, was first approved by FDA on Dec 19, 1977, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1977
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 19, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Oct 1, 1998	Supplement 23Manufacturing	Approved	None posted
Jun 23, 1998	Supplement 22Manufacturing	Approved	None posted
Jun 23, 1998	Supplement 21Manufacturing	Approved	None posted
Dec 2, 1994	Supplement 20Manufacturing	Approved	None posted
Mar 26, 1991	Supplement 19Manufacturing	Approved	None posted
Mar 26, 1991	Supplement 17Manufacturing	Approved	None posted
Mar 26, 1991	Supplement 16Manufacturing	Approved	None posted
Jul 20, 1989	Supplement 18Bioequivalence	Approved	None posted
May 2, 1985	Supplement 15Manufacturing	Approved	None posted
Sep 27, 1984	Supplement 14Manufacturing	Approved	None posted
May 6, 1983	Supplement 13Manufacturing	Approved	None posted
Aug 5, 1982	Supplement 12Manufacturing	Approved	None posted
Mar 15, 1982	Supplement 9Manufacturing	Approved	None posted
Mar 15, 1982	Supplement 8Manufacturing	Approved	None posted
Dec 19, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85961
Drugs@FDA: Overview at FDA
Company: Clonmel Healthcare

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