Soma

Relieves discomfort associated with acute, painful musculoskeletal conditions. NDA 11792, held by Mylan Speciality LP. Carisoprodol.

As of Nov 13, 2026, NDA 11792 (Soma), held by Mylan Speciality LP, was first approved by FDA on Apr 9, 1959, with 27 approved supplements and 0 published complete response letters.

First approved: Apr 9, 1959
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Sep 13, 2007	Supplement 41Efficacy (new indication or use)	Approved	Review Letter Label
Apr 9, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Soma350MG · tablet;oral	Carisoprodol	RxReference drug
Soma250MG · capsule;oral	Carisoprodol	DiscontinuedReference drug
Soma250MG · tablet;oral	Carisoprodol	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


Apr 4, 2019	Supplement 50Labeling · Standard review	Approved	Letter Label
Aug 22, 2018	Supplement 48Labeling · Standard review	Approved	Label
Feb 23, 2015	Supplement 46Labeling · Standard review	Approved	Letter
Feb 1, 2013	Supplement 45Labeling · Standard review	Approved	Label Letter
Nov 17, 2009	Supplement 43Labeling · Standard review	Approved	Letter Label
Nov 6, 2009	Supplement 42Manufacturing	Approved	None posted
Sep 13, 2007	Supplement 41Efficacy (new indication or use)	Approved	Review Letter Label
Jun 7, 2006	Supplement 35Labeling · Standard review	Approved	Letter Label
Dec 29, 1999	Supplement 36Manufacturing · Standard review	Approved	None posted
Mar 2, 1994	Supplement 31Manufacturing · Standard review	Approved	None posted
Oct 25, 1993	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 27, 1987	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 10, 1987	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 1, 1987	Supplement 29Manufacturing · Standard review	Approved	None posted
Oct 27, 1986	Supplement 28Labeling	Approved	None posted
Apr 30, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 19, 1983	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 18, 1983	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 18, 1983	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 27, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 5, 1979	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 30, 1979	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 13, 1979	Supplement 20Manufacturing · Standard review	Approved	None posted
May 20, 1975	Supplement 17Labeling	Approved	None posted
Dec 13, 1974	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 8, 1974	Supplement 16Labeling	Approved	None posted
Jul 19, 1974	Supplement 15Labeling	Approved	None posted
Apr 9, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11792
Drugs@FDA: Overview at FDA
Company: Mylan Specialty

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