Drugs@FDA: FDA-Approved Drugs
Company: APIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| NORCO | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 02/14/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/22/2021 | SUPPL-75 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040148s073lbl.pdf | |
| 09/20/2018 | SUPPL-72 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-71 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 02/06/2017 | SUPPL-68 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-67 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2016 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040148s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040148s053ltr.pdf | |
| 04/07/2017 | SUPPL-51 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2011 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/09/2008 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/30/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/21/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf |
| 10/29/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf |
| 09/12/2000 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf |
| 09/12/2000 | SUPPL-3 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf |
| 09/12/2000 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040148s.pdf |
| 10/07/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040148s073lbl.pdf | |
| 12/19/2014 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040148s053lbl.pdf |