Drugs@FDA: FDA-Approved Drugs
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| ASPIRIN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FIORINAL | ASPIRIN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017534s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017534Orig1s074ltr.pdf | |
| 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. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017534s074lbl.pdf |