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OXYCODONE TEREPHTHALATE 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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OXYCODONE TEREPHTHALATE 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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