Methocarbamol

ANDA 84928, held by Impax Labs. Methocarbamol.

As of Nov 14, 2026, ANDA 84928 (Methocarbamol), held by Impax Labs, was first approved by FDA on Aug 20, 1976, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 20, 1976
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol750MG · tablet;oral	Methocarbamol	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Sep 28, 1989	Supplement 31Labeling	Approved	None posted
Dec 19, 1988	Supplement 30Labeling	Approved	None posted
Jun 10, 1988	Supplement 29Labeling	Approved	None posted
Apr 18, 1988	Supplement 26Manufacturing	Approved	None posted
Nov 14, 1987	Supplement 28Manufacturing	Approved	None posted
Sep 3, 1987	Supplement 27Manufacturing	Approved	None posted
Jul 2, 1987	Supplement 25Manufacturing	Approved	None posted
Aug 15, 1986	Supplement 23Manufacturing	Approved	None posted
Aug 15, 1986	Supplement 24Manufacturing	Approved	None posted
Aug 20, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84928
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