Robaxin

Relieves discomfort associated with acute, painful musculoskeletal conditions. NDA 11790, held by Hikma. Methocarbamol.

As of Nov 13, 2026, NDA 11790 (Robaxin), held by Hikma, was first approved by FDA on Jun 10, 1959, with 23 approved supplements and 0 published complete response letters.

First approved: Jun 10, 1959
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE The injectable form of 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 this drug 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 24 submissions below

Date	Submission	Status	Documents
Jun 10, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Robaxin1GM/10ML (100MG/ML) · solution;im-iv	Methocarbamol	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Aug 12, 2014	Supplement 51Manufacturing · Standard review	Approved	None posted
Apr 29, 2014	Supplement 50Manufacturing · Standard review	Approved	None posted
May 4, 2004	Supplement 46Labeling · Standard review	Approved	Label Letter
Feb 28, 2001	Supplement 42Manufacturing · Standard review	Approved	None posted
Dec 29, 1999	Supplement 41Manufacturing · Standard review	Approved	None posted
Apr 22, 1998	Supplement 40Manufacturing · Standard review	Approved	None posted
Dec 11, 1990	Supplement 38Manufacturing · Standard review	Approved	None posted
Dec 2, 1988	Supplement 37Manufacturing · Standard review	Approved	None posted
Jan 22, 1987	Supplement 36Manufacturing · Standard review	Approved	None posted
Jan 7, 1987	Supplement 35Manufacturing · Standard review	Approved	None posted
Jan 3, 1986	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 20, 1983	Supplement 32Labeling	Approved	None posted
Dec 16, 1982	Supplement 33Manufacturing · Standard review	Approved	None posted
Sep 3, 1982	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 22, 1982	Supplement 28Labeling	Approved	None posted
Sep 29, 1981	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 10, 1981	Supplement 27Labeling	Approved	None posted
May 23, 1980	Supplement 25Manufacturing · Standard review	Approved	None posted
May 23, 1980	Supplement 24Manufacturing · Standard review	Approved	None posted
May 1, 1980	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 3, 1980	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 17, 1979	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 11, 1976	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 10, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11790
Drugs@FDA: Overview at FDA
Company: Hikma

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