Methocarbamol

ANDA 86459, held by Dr Reddys. Methocarbamol.

As of Nov 14, 2026, ANDA 86459 (Methocarbamol), held by Dr Reddys, was first approved by FDA on Jul 3, 1980, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1980
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jul 3, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol100MG/ML · injectable;injection	Methocarbamol	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 39Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 38Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 37Manufacturing	Approved	None posted
Sep 3, 1993	Supplement 35Manufacturing	Approved	None posted
Jun 23, 1992	Supplement 36Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 31Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 32Manufacturing	Approved	None posted
Dec 8, 1988	Supplement 33Manufacturing	Approved	None posted
Jun 17, 1987	Supplement 25Manufacturing	Approved	None posted
May 20, 1986	Supplement 22Manufacturing	Approved	None posted
May 20, 1986	Supplement 23Manufacturing	Approved	None posted
Jul 3, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 86459
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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