Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007337
Company: ENDO PHARMS
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OXYCODONE TEREPHTHALATE 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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OXYCODONE TEREPHTHALATE 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
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-Package Insert, Labeling-Medication Guide, 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.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
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 090084 ACTAVIS LABS FL INC
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription No AA 091670 MAYNE PHARMA INC
PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription Yes AA 007337 ENDO PHARMS

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 090084 ACTAVIS LABS FL INC
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription No AA 091670 MAYNE PHARMA INC
PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription Yes AA 007337 ENDO PHARMS

PERCODAN-DEMI

There are no Therapeutic Equivalents.

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