Fiorinal

NDA 17534, held by Allergan. Aspirin; Butalbital; Caffeine.

As of Nov 14, 2026, NDA 17534 (Fiorinal), held by Allergan, was first approved by FDA on May 4, 1976, with 52 approved supplements and 0 published complete response letters.

First approved: May 4, 1976
Review: Standard
Supplements approved: 52
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 53 submissions below

Date	Submission	Status	Documents
May 4, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Fiorinal325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aspirin; Butalbital; Caffeine	DiscontinuedReference drug
Fiorinal325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Aspirin; Butalbital; Caffeine	DiscontinuedReference drug

All 53 submissions, including labeling and manufacturing supplements


Apr 28, 2021	Supplement 74Labeling · Standard review	Approved	Letter Label
Oct 16, 2014	Supplement 73Manufacturing · Standard review	Approved	None posted
Jul 21, 2014	Supplement 72Manufacturing · Standard review	Approved	None posted
Jun 3, 2013	Supplement 71Manufacturing · Standard review	Approved	None posted
Apr 26, 2002	Supplement 56Manufacturing · Standard review	Approved	None posted
Jun 28, 2001	Supplement 55Manufacturing · Standard review	Approved	None posted
May 30, 2001	Supplement 54Manufacturing · Standard review	Approved	None posted
Nov 10, 1999	Supplement 51Manufacturing · Standard review	Approved	None posted
Apr 22, 1999	Supplement 50Manufacturing · Standard review	Approved	None posted
Mar 1, 1999	Supplement 49Manufacturing · Standard review	Approved	None posted
Feb 27, 1997	Supplement 40Labeling	Approved	None posted
Jan 18, 1996	Supplement 45Labeling · Standard review	Approved	None posted
Nov 24, 1995	Supplement 48Manufacturing · Standard review	Approved	None posted
Oct 20, 1995	Supplement 46Manufacturing · Standard review	Approved	None posted
Apr 5, 1995	Supplement 43Manufacturing · Standard review	Approved	None posted
May 18, 1994	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 5, 1994	Supplement 44Manufacturing · Standard review	Approved	None posted
Mar 19, 1993	Supplement 41Manufacturing · Standard review	Approved	None posted
Mar 19, 1993	Supplement 42Manufacturing · Standard review	Approved	None posted
Aug 14, 1992	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 27, 1992	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 27, 1992	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 27, 1992	Supplement 38Labeling	Approved	None posted
Jul 22, 1992	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 22, 1992	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 22, 1992	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 7, 1989	Supplement 31Manufacturing · Standard review	Approved	None posted
Nov 17, 1988	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 31, 1988	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 16, 1986	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 15, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 15, 1985	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 11, 1984	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 10, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 10, 1981	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 29, 1981	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 18, 1980	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 21, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 14, 1979	Supplement 14Manufacturing · Standard review	Approved	None posted
May 31, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
May 31, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 11, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 15, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 13, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 12, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 6, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 21, 1978	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 21, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 14, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 31, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 30, 1976	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 30, 1976	Supplement 2Manufacturing · Standard review	Approved	None posted
May 4, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Show all 53

Identifiers

Application: NDA 17534
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