Methocarbamol

ANDA 87282, held by Sandoz. Methocarbamol.

As of Nov 14, 2026, ANDA 87282 (Methocarbamol), held by Sandoz, was first approved by FDA on Sep 16, 1994, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 16, 1994
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 16, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methocarbamol750MG · tablet;oral	Methocarbamol	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 4, 1994	Supplement 9Manufacturing	Approved	None posted
Oct 14, 1994	Supplement 8Manufacturing	Approved	None posted
Sep 16, 1994	Original application	Approved	None posted
Dec 31, 1985	Supplement 7Manufacturing	Approved	None posted
Sep 22, 1982	Supplement 1Manufacturing	Approved	None posted

Identifiers

Application: ANDA 87282
Drugs@FDA: Overview at FDA
Company: Sandoz

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