Soma Compound W/ Codeine

NDA 12366, held by Meda Pharms. Aspirin; Carisoprodol; Codeine Phosphate.

As of Nov 14, 2026, NDA 12366 (Soma Compound W/ Codeine), held by Meda Pharms, was first approved by FDA on Oct 5, 1960, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 5, 1960
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 5, 1960	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Soma Compound W/ Codeine325MG;200MG;16MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aspirin; Carisoprodol; Codeine Phosphate	Discontinued

All 20 submissions, including labeling and manufacturing supplements


May 9, 2013	Supplement 34Labeling · Standard review	Approved	Label Letter
Jan 31, 2013	Supplement 33Labeling · Standard review	Approved	Letter Label
Nov 6, 2009	Supplement 32Labeling · Standard review	Approved	Letter Label
Oct 23, 2008	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 22, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 2, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 15, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 22, 1993	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 16, 1986	Supplement 21Labeling · Standard review	Approved	None posted
Feb 23, 1984	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 11, 1983	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 19, 1983	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 5, 1983	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 5, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 23, 1982	Supplement 13Labeling · Standard review	Approved	None posted
Nov 16, 1981	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 16, 1981	Supplement 9Labeling · Standard review	Approved	None posted
Oct 29, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 19, 1974	Supplement 6Labeling · Standard review	Approved	None posted
Oct 5, 1960	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12366
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