Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021180
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORTHO EVRA ETHINYL ESTRADIOL; NORELGESTROMIN 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None Yes No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
11/20/2001 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_Ortho%20EVRA_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_ORTHO.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021180s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021180Orig1s048ltr.pdf
10/22/2015 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021180s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021180Orig1s047ltr.pdf
04/11/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021180Orig1s046ltr.pdf
07/01/2013 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021180s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021180Orig1s044ltr.pdf
08/22/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021180Orig1s043ltr.pdf
04/12/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/28/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s040ltr.pdf
03/23/2011 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s039ltr.pdf
07/26/2011 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021180s038ltr.pdf
04/12/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/13/2010 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021180s035ltr.pdf
12/01/2009 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s034ltr.pdf
09/11/2009 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s033ltr.pdf
10/30/2008 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028,%20s030,%20s031ltr.pdf
10/30/2008 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf
07/29/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021180s029ltr.pdf
10/30/2008 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021180s028, s030, s031ltr.pdf
01/18/2008 SUPPL-26 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s026lbl.pdf
09/20/2006 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s022ltr.pdf
05/17/2006 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021180s020LTR.pdf
11/10/2005 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s019ltr.pdf
05/06/2005 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021180s015ltr.pdf
11/24/2004 SUPPL-14 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180s014ltr.pdf
02/04/2004 SUPPL-8 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21180slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021180_s008_ORTHO EVRA.pdf
06/18/2002 SUPPL-5 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21180_S005_OrthoEvraTOC.cfm
10/02/2002 SUPPL-4 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s004_OrthoTOC.cfm
11/14/2002 SUPPL-3 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s003_OrthoTOC.cfm
08/09/2002 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s002_ORTHO EVRA.pdf
03/04/2002 SUPPL-1 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021180_s001_ORTHO EVRA.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2017 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021180s048lbl.pdf
10/22/2015 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021180s047lbl.pdf
04/11/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021180Orig1s046lbl.pdf
07/01/2013 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021180s044lbl.pdf
08/22/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021180s043lbl.pdf
12/28/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s040lbl.pdf
07/26/2011 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s038lbl.pdf
03/23/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021180s039lbl.pdf
04/13/2010 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021180s035lbl.pdf
12/01/2009 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s034lbl.pdf
09/11/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s033lbl.pdf
07/29/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021180s029lbl.pdf
10/30/2008 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf
10/30/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf
10/30/2008 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s028s030s031lbl.pdf
01/18/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021180s026lbl.pdf
09/20/2006 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021180s022lbl.pdf
11/10/2005 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s019lbl.pdf
05/06/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021180s015lbl.pdf
11/20/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21180lbl.pdf

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