Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017534
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIORINAL ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
FIORINAL ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/04/1976 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2014 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

07/21/2014 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

06/03/2013 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

04/26/2002 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2001 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

05/30/2001 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1999 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1995 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1996 SUPPL-45 Labeling

Label is not available on this site.

04/05/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1993 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/19/1993 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/27/1997 SUPPL-40 Labeling

Label is not available on this site.

08/14/1992 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1992 SUPPL-38 Labeling

Label is not available on this site.

07/22/1992 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/27/1992 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1992 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1992 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1989 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1988 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1994 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/1988 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/15/1985 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/15/1985 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/11/1984 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1986 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/10/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/10/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/29/1981 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1980 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/21/1979 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1979 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/31/1979 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1979 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/1979 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/15/1978 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/12/1978 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1978 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1978 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/14/1977 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/21/1978 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/21/1978 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1977 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/1976 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1976 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

FIORINAL

CAPSULE;ORAL; 325MG;50MG;40MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FIORINAL ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription Yes AA 017534 ALLERGAN
LANORINAL ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 086996 LANNETT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English