Methocarbamol

ANDA 85159, held by Hikma Intl Pharms. Methocarbamol.

As of Nov 14, 2026, ANDA 85159 (Methocarbamol), held by Hikma Intl Pharms, was first approved by FDA on Aug 11, 1976, with 26 approved supplements and 0 published complete response letters.

First approved: Aug 11, 1976
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Aug 11, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Dec 7, 2015	Supplement 51Labeling · Standard review	Approved	None posted
Oct 28, 2002	Supplement 42Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 41Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 38Labeling	Approved	None posted
Mar 11, 1999	Supplement 36Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 35Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 34Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 33Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 39Manufacturing	Approved	None posted
Feb 22, 1996	Supplement 32Labeling	Approved	None posted
Feb 22, 1996	Supplement 31Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 30Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 29Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 28Manufacturing	Approved	None posted
Dec 2, 1992	Supplement 27Labeling	Approved	None posted
Sep 17, 1990	Supplement 23Manufacturing	Approved	None posted
May 2, 1989	Supplement 19Labeling	Approved	None posted
Feb 4, 1987	Supplement 20Manufacturing	Approved	None posted
Apr 9, 1986	Supplement 16Manufacturing	Approved	None posted
Apr 9, 1986	Supplement 15Manufacturing	Approved	None posted
Apr 9, 1986	Supplement 14Manufacturing	Approved	None posted
Nov 20, 1984	Supplement 13Manufacturing	Approved	None posted
Jun 27, 1984	Supplement 12Manufacturing	Approved	None posted
Apr 21, 1982	Supplement 5Manufacturing	Approved	None posted
Apr 1, 1982	Supplement 4Manufacturing	Approved	None posted
Apr 1, 1982	Supplement 3Manufacturing	Approved	None posted
Aug 11, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85159
Drugs@FDA: Overview at FDA
Company: Hikma International 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