Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019429
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FIORINAL W/CODEINE | ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/26/1990 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 12/16/2016 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019429s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019429Orig1s044,s045ltr.pdf | |
| 04/28/2021 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019429s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019429Orig1s044,s045ltr.pdf | |
| 10/07/2019 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019429Orig1s043ltr.pdf | |
| 09/18/2018 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019429Orig1s041s042ltr.pdf | |
| 09/18/2018 | SUPPL-41 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019429Orig1s041s042ltr.pdf | |
| 08/29/2017 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019429Orig1s040ltr.pdf | |
| 12/16/2016 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019429Orig1s039ltr.pdf | |
| 11/06/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019429Orig1s035ltr.pdf | |
| 04/08/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019429s023ltr.pdf | |
| 04/26/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/12/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19429slr006ltr.pdf |
| 04/05/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1993 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/1993 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-1 | Labeling |
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-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019429s045lbl.pdf | |
| 04/28/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019429s044s045lbl.pdf | |
| 10/07/2019 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf | |
| 10/07/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf | |
| 09/18/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf | |
| 09/18/2018 | SUPPL-41 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf | |
| 08/29/2017 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf | |
| 08/29/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf | |
| 12/16/2016 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf | |
| 12/16/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf | |
| 12/16/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019429s039lbl.pdf | |
| 05/09/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019429s035lbl.pdf | |
| 04/08/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf |