Methocarbamol

ANDA 84927, held by Impax Labs. Methocarbamol.

As of Nov 14, 2026, ANDA 84927 (Methocarbamol), held by Impax Labs, was first approved by FDA on Aug 20, 1976, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 20, 1976
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 20, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jan 25, 1989	Supplement 31Labeling	Approved	None posted
Dec 22, 1988	Supplement 30Labeling	Approved	None posted
Apr 15, 1988	Supplement 27Manufacturing	Approved	None posted
Nov 10, 1987	Supplement 29Manufacturing	Approved	None posted
Sep 3, 1987	Supplement 28Manufacturing	Approved	None posted
Jul 2, 1987	Supplement 26Manufacturing	Approved	None posted
Aug 15, 1986	Supplement 25Manufacturing	Approved	None posted
Aug 15, 1986	Supplement 24Manufacturing	Approved	None posted
Dec 20, 1983	Supplement 23Manufacturing	Approved	None posted
Dec 20, 1983	Supplement 22Manufacturing	Approved	None posted
Aug 20, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84927
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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