Methocarbamol

ANDA 85123, held by Hikma. Methocarbamol.

As of Nov 14, 2026, ANDA 85123 (Methocarbamol), held by Hikma, was first approved by FDA on Aug 18, 1976, with 27 approved supplements and 0 published complete response letters.

First approved: Aug 18, 1976
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Aug 18, 1976	Original application	Approved	None posted

Products

2 strengths and forms


Methocarbamol750MG · tablet;oral	Methocarbamol	Discontinued
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 28 submissions, including labeling and manufacturing supplements


May 8, 2015	Supplement 49Labeling · Standard review	Approved	None posted
Oct 28, 2002	Supplement 39Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 38Manufacturing	Approved	None posted
Oct 2, 2000	Supplement 37Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 34Labeling	Approved	None posted
Mar 11, 1999	Supplement 32Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 31Manufacturing	Approved	None posted
Mar 11, 1999	Supplement 30Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 35Manufacturing	Approved	None posted
Feb 22, 1996	Supplement 28Labeling	Approved	None posted
Feb 22, 1996	Supplement 27Manufacturing	Approved	None posted
Nov 8, 1995	Supplement 29Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 26Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 25Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 24Manufacturing	Approved	None posted
Dec 17, 1992	Supplement 23Labeling	Approved	None posted
Nov 21, 1990	Supplement 19Manufacturing	Approved	None posted
May 2, 1989	Supplement 18Labeling	Approved	None posted
May 2, 1989	Supplement 15Labeling	Approved	None posted
Feb 4, 1987	Supplement 16Manufacturing	Approved	None posted
Apr 9, 1986	Supplement 12Manufacturing	Approved	None posted
Apr 9, 1986	Supplement 11Manufacturing	Approved	None posted
Apr 9, 1986	Supplement 10Manufacturing	Approved	None posted
May 19, 1982	Supplement 8Manufacturing	Approved	None posted
May 19, 1982	Supplement 7Manufacturing	Approved	None posted
May 19, 1982	Supplement 3Manufacturing	Approved	None posted
May 19, 1982	Supplement 2Manufacturing	Approved	None posted
Aug 18, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85123
Drugs@FDA: Overview at FDA
Company: Hikma

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