Fiorinal W/Codeine

NDA 19429, held by Allergan. Aspirin; Butalbital; Caffeine; Codeine Phosphate.

As of Nov 13, 2026, NDA 19429 (Fiorinal W/Codeine), held by Allergan, was first approved by FDA on Oct 26, 1990, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1990
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Oct 26, 1990	Original applicationNew combination · Standard review	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fiorinal W/Codeine325MG;50MG;40MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Aspirin; Butalbital; Caffeine; Codeine Phosphate	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 45Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 44Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 43Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 42Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 41REMS	Approved	Label Letter
Aug 29, 2017	Supplement 40Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 49Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 39Labeling · Standard review	Approved	Label Letter
Nov 6, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Nov 16, 2014	Supplement 37Manufacturing · Standard review	Approved	None posted
May 9, 2013	Supplement 35Labeling · Standard review	Approved	Label Letter
Apr 8, 2008	Supplement 23Labeling · Standard review	Approved	Label Letter Other
Aug 26, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Apr 26, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 4, 2001	Supplement 16Labeling · Standard review	Approved	None posted
Jun 28, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
May 30, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 10, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 22, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 12, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 21, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 20, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 20, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 5, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 6, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 6, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 6, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 1Labeling	Approved	None posted
Oct 26, 1990	Original applicationNew combination · Standard review	Approved	REMS

Identifiers

Application: NDA 19429
Drugs@FDA: Overview at FDA
Company: Allergan

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