Methocarbamol

Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 200958, held by Bostal. Methocarbamol.

As of Nov 14, 2026, ANDA 200958 (Methocarbamol), held by Bostal, was first approved by FDA on Oct 21, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 21, 2011
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 21, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Methocarbamol500MG · tablet;oral	Methocarbamol	Rx
Methocarbamol750MG · tablet;oral	Methocarbamol	Rx
Methocarbamol1GM · tablet;oral	Methocarbamol	Rx

All 3 submissions, including labeling and manufacturing supplements


Oct 12, 2022	Supplement 20Manufacturing	Approved	None posted
Jul 15, 2022	Supplement 19Manufacturing	Approved	None posted
Oct 21, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200958
Drugs@FDA: Overview at FDA
Company: Bostal

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