Soma Compound

NDA 12365, held by Meda Pharms. Aspirin; Carisoprodol.

As of Nov 13, 2026, NDA 12365 (Soma Compound), held by Meda Pharms, was first approved by FDA on Sep 12, 1960, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 12, 1960
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 12, 1960	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Soma Compound325MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aspirin; Carisoprodol	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jan 31, 2013	Supplement 39Labeling · Standard review	Approved	Letter Label
Nov 17, 2009	Supplement 38Labeling	Approved	Letter Label
Apr 1, 2009	Supplement 35Labeling · Standard review	Approved	Letter Label
Mar 2, 2000	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 25, 1993	Supplement 33Manufacturing · Standard review	Approved	None posted
Sep 30, 1986	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 10, 1986	Supplement 30Labeling	Approved	None posted
Jul 11, 1983	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 19, 1983	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 5, 1983	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 5, 1983	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 11, 1983	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 29, 1981	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 15, 1980	Supplement 20Labeling	Approved	None posted
Dec 12, 1974	Supplement 14Labeling	Approved	None posted
Dec 12, 1974	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 19, 1974	Supplement 13Labeling	Approved	None posted
Sep 12, 1960	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12365
Drugs@FDA: Overview at FDA
Company: Meda 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