Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007337
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | AA | Yes | Yes |
| PERCODAN-DEMI | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/12/1950 | 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 |
|---|---|---|---|---|---|
| 04/19/2024 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/007337s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/007337Orig1s055ltr.pdf | |
| 12/15/2023 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/007337s054lbl.pdf | |
| 04/28/2021 | SUPPL-53 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/007337Orig1s053ltr.pdf | |
| 10/07/2019 | SUPPL-52 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/007337Orig1s052ltr.pdf | |
| 09/18/2018 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/007337Orig1s050s051ltr.pdf | |
| 09/18/2018 | SUPPL-50 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/007337Orig1s050s051ltr.pdf | |
| 12/16/2016 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/007337Orig1s049ltr.pdf | |
| 01/21/2014 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2013 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/2010 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/007337s046ltr.pdf | |
| 03/11/2010 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/007337s045ltr.pdf | |
| 08/11/2006 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/007337s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/07337s043LTR.pdf | |
| 04/29/2002 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2004 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07337slr029_percodan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07337slr029ltr.pdf | |
| 03/17/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/1994 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-24 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/007337-S24_Percodan_toc.cfm |
| 04/20/1994 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/03/1983 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/04/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1980 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/28/1976 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1975 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/19/2024 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/007337s055lbl.pdf | |
| 12/15/2023 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/007337s054lbl.pdf | |
| 12/15/2023 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/007337s054lbl.pdf | |
| 04/28/2021 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf | |
| 04/28/2021 | SUPPL-53 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf | |
| 10/07/2019 | SUPPL-52 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf | |
| 10/07/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf | |
| 09/18/2018 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf | |
| 09/18/2018 | SUPPL-50 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf | |
| 12/16/2016 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf | |
| 12/16/2016 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf | |
| 12/16/2016 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf | |
| 07/28/2010 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s046lbl.pdf | |
| 03/11/2010 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/007337s045lbl.pdf | |
| 08/11/2006 | SUPPL-43 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/007337s043lbl.pdf | |
| 06/10/2004 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07337slr029_percodan_lbl.pdf |
PERCODAN
TABLET;ORAL; 325MG;4.8355MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | No | AA | 040910 | EPIC PHARMA LLC |
| PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | Yes | AA | 007337 | ENDO OPERATIONS |
PERCODAN
TABLET;ORAL; 325MG;4.8355MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | No | AA | 040910 | EPIC PHARMA LLC |
| PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE | 325MG;4.8355MG | TABLET;ORAL | Prescription | Yes | AA | 007337 | ENDO OPERATIONS |
PERCODAN-DEMI
There are no Therapeutic Equivalents.