Methocarbamol

ANDA 84276, held by Ani Pharms. Methocarbamol.

As of Nov 14, 2026, ANDA 84276 (Methocarbamol), held by Ani Pharms, was first approved by FDA on Jan 4, 1977, with 24 approved supplements and 0 published complete response letters.

First approved: Jan 4, 1977
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jan 4, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol750MG · tablet;oral	Methocarbamol	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Sep 28, 2007	Supplement 52Labeling	Approved	None posted
Nov 13, 2002	Supplement 47Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 46Manufacturing	Approved	None posted
Jun 8, 1999	Supplement 45Manufacturing	Approved	None posted
Jun 8, 1999	Supplement 44Manufacturing	Approved	None posted
Sep 22, 1998	Supplement 42Labeling	Approved	None posted
Sep 22, 1998	Supplement 41Manufacturing	Approved	None posted
Sep 22, 1998	Supplement 40Manufacturing	Approved	None posted
Sep 22, 1998	Supplement 39Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 36Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 35Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 34Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 33Manufacturing	Approved	None posted
Sep 2, 1988	Supplement 32Bioequivalence	Approved	None posted
Feb 26, 1987	Supplement 31Manufacturing	Approved	None posted
Aug 16, 1985	Supplement 25Manufacturing	Approved	None posted
Aug 2, 1985	Supplement 29Manufacturing	Approved	None posted
Aug 2, 1985	Supplement 28Manufacturing	Approved	None posted
Aug 2, 1985	Supplement 27Manufacturing	Approved	None posted
Aug 2, 1985	Supplement 26Manufacturing	Approved	None posted
Apr 4, 1984	Supplement 24Manufacturing	Approved	None posted
Nov 16, 1983	Supplement 20Manufacturing	Approved	None posted
Dec 16, 1982	Supplement 23Manufacturing	Approved	None posted
Apr 5, 1982	Supplement 19Manufacturing	Approved	None posted
Jan 4, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 84276
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