Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021611
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPANA OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No
OPANA OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes 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
06/22/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021611s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021610s000_021611s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021611Orig1s017ltr.pdf
10/25/2019 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021611Orig1s016ltr.pdf
09/18/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021611Orig1s013s015ltr.pdf
09/18/2018 SUPPL-13 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021611Orig1s013s015ltr.pdf
12/22/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021611Orig1s010ltr.pdf
09/17/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/09/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021611Orig1s007ltr.pdf
02/03/2011 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021611s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021611s005ltr.pdf
04/15/2010 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021611s004ltr.pdf
08/02/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2019 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf
10/07/2019 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf
10/07/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf
09/18/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf
09/18/2018 SUPPL-13 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf
12/16/2016 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf
12/16/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf
07/09/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf
02/03/2011 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021611s005lbl.pdf
08/02/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf
06/22/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf

OPANA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OPANA OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021611 ENDO PHARMS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 210175 ASCENT PHARMS INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204459 AUROLIFE PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 203601 AVANTHI INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201187 EPIC PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090964 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202321 SPECGX LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091443 TEVA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OPANA OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021611 ENDO PHARMS
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 210175 ASCENT PHARMS INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204459 AUROLIFE PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 203601 AVANTHI INC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201187 EPIC PHARMA LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090964 HIKMA
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202321 SPECGX LLC
OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091443 TEVA

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