Methocarbamol

ANDA 84756, held by Chartwell Molecular. Methocarbamol.

As of Nov 14, 2026, ANDA 84756 (Methocarbamol), held by Chartwell Molecular, was first approved by FDA on Nov 23, 1976, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 23, 1976
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 23, 1976	Original application	Approved	None posted

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Nov 1, 2007	Supplement 11Labeling	Approved	None posted
May 31, 2003	Supplement 5Manufacturing	Approved	None posted
Mar 31, 2003	Supplement 7Labeling	Approved	None posted
Mar 31, 2003	Supplement 6Manufacturing	Approved	None posted
Aug 10, 2000	Supplement 4Manufacturing	Approved	None posted
Jul 6, 1983	Supplement 3Manufacturing	Approved	None posted
Nov 23, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84756
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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