Methocarbamol

Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 40489, held by Oxford Pharms. Methocarbamol.

As of Nov 14, 2026, ANDA 40489 (Methocarbamol), held by Oxford Pharms, was first approved by FDA on Jan 29, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2003
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
Jan 29, 2003	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jul 2, 2020	Supplement 15Labeling · Standard review	Approved	None posted
May 5, 2005	Supplement 1Labeling	Approved	None posted
Jan 29, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40489
Drugs@FDA: Overview at FDA
Company: Oxford Pharmaceuticals

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