Methocarbamol

ANDA 84488, held by Sun Pharm Industries. Methocarbamol.

As of Nov 14, 2026, ANDA 84488 (Methocarbamol), held by Sun Pharm Industries, was first approved by FDA on Jul 11, 1975, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 11, 1975
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jul 11, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol500MG · tablet;oral	Methocarbamol	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 50Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 49Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 48Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 45Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 47Manufacturing	Approved	None posted
Mar 3, 1989	Supplement 44Labeling	Approved	None posted
Dec 17, 1987	Supplement 41Manufacturing	Approved	None posted
Apr 6, 1987	Supplement 42Manufacturing	Approved	None posted
Mar 7, 1986	Supplement 38Manufacturing	Approved	None posted
Nov 19, 1985	Supplement 33Manufacturing	Approved	None posted
Jun 6, 1985	Supplement 36Manufacturing	Approved	None posted
Mar 23, 1984	Supplement 34Manufacturing	Approved	None posted
Jun 10, 1983	Supplement 32Manufacturing	Approved	None posted
Jul 11, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84488
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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