Methocarbamol

ANDA 84277, held by Ani Pharms. Methocarbamol.

As of Nov 14, 2026, ANDA 84277 (Methocarbamol), held by Ani Pharms, was first approved by FDA on Mar 14, 1977, with 23 approved supplements and 0 published complete response letters.

First approved: Mar 14, 1977
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Mar 14, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Sep 28, 2007	Supplement 48Labeling	Approved	None posted
Nov 13, 2002	Supplement 43Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 42Manufacturing	Approved	None posted
Aug 13, 1999	Supplement 40Manufacturing	Approved	None posted
Aug 13, 1999	Supplement 41Manufacturing	Approved	None posted
Sep 22, 1998	Supplement 36Manufacturing	Approved	None posted
Sep 22, 1998	Supplement 37Manufacturing	Approved	None posted
Sep 22, 1998	Supplement 38Labeling	Approved	None posted
Aug 7, 1991	Supplement 34Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 35Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 33Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 31Manufacturing	Approved	None posted
Apr 15, 1988	Supplement 29Labeling	Approved	None posted
May 18, 1987	Supplement 25Manufacturing	Approved	None posted
May 18, 1987	Supplement 26Manufacturing	Approved	None posted
May 18, 1987	Supplement 27Manufacturing	Approved	None posted
Feb 26, 1987	Supplement 24Manufacturing	Approved	None posted
May 12, 1986	Supplement 19Manufacturing	Approved	None posted
May 12, 1986	Supplement 20Manufacturing	Approved	None posted
Aug 2, 1985	Supplement 21Manufacturing	Approved	None posted
Aug 2, 1985	Supplement 22Manufacturing	Approved	None posted
Jul 1, 1982	Supplement 14Manufacturing	Approved	None posted
Jul 1, 1982	Supplement 15Manufacturing	Approved	None posted
Mar 14, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 84277
Drugs@FDA: Overview at FDA
Company: ANI 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