Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040330
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | AA | No | Yes |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | AA | No | Yes |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | AA | No | Yes |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | AA | No | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40330ltr..pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-330_Oxycodone%20and%20Acetaminophen.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-62 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/03/2024 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-59 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/040330s052lbl.pdf | |
| 09/18/2018 | SUPPL-50 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-44 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2012 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2006 | SUPPL-15 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf | |
| 03/16/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/18/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/02/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/21/2018 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/040330s052lbl.pdf | |
| 11/30/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf |
PERCOCET
TABLET;ORAL; 325MG;2.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 210644 | ABHAI LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 201447 | ACTAVIS ELIZABETH |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 207419 | ASCENT PHARMS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 201972 | AUROLIFE PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 211708 | GRANULES |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 204407 | NOVEL LABS INC |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Prescription | No | AA | 040330 | ENDO OPERATIONS |
TABLET;ORAL; 325MG;5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 087463 | SPECGX LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 210644 | ABHAI LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 201447 | ACTAVIS ELIZABETH |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 202677 | ALVOGEN |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 040777 | AMNEAL PHARMS |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 207419 | ASCENT PHARMS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 201972 | AUROLIFE PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 207834 | CHARTWELL |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 209385 | ELITE LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 203864 | EPIC PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 211708 | GRANULES |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 204407 | NOVEL LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 201278 | RHODES PHARMS |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 207510 | WES PHARMA INC |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Prescription | No | AA | 040330 | ENDO OPERATIONS |
TABLET;ORAL; 325MG;7.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 210644 | ABHAI LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 201447 | ACTAVIS ELIZABETH |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 202677 | ALVOGEN |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040778 | AMNEAL PHARMS NY |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 207419 | ASCENT PHARMS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 201972 | AUROLIFE PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 207834 | CHARTWELL |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 209385 | ELITE LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 203864 | EPIC PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 211708 | GRANULES |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 204407 | NOVEL LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 201278 | RHODES PHARMS |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040545 | SPECGX LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 207510 | WES PHARMA INC |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Prescription | No | AA | 040330 | ENDO OPERATIONS |
TABLET;ORAL; 325MG;10MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 210644 | ABHAI LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 201447 | ACTAVIS ELIZABETH |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 202677 | ALVOGEN |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 040778 | AMNEAL PHARMS NY |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 207419 | ASCENT PHARMS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 201972 | AUROLIFE PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 207834 | CHARTWELL |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 209385 | ELITE LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 203864 | EPIC PHARMA LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 211708 | GRANULES |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 204407 | NOVEL LABS INC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 201278 | RHODES PHARMS |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 040545 | SPECGX LLC |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 207510 | WES PHARMA INC |
| PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Prescription | No | AA | 040330 | ENDO OPERATIONS |