Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021529
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMPLANON ETONOGESTREL 68MG/IMPLANT IMPLANT;IMPLANTATION Discontinued None No No
NEXPLANON ETONOGESTREL 68MG/IMPLANT IMPLANT;IMPLANTATION Prescription None 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
07/17/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021529s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021529_implanon_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2019 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021529Orig1s018ltr.pdf
05/19/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021529s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021529Orig1s015ltr.pdf
03/14/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021529Orig1s013ltr.pdf
09/03/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/19/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021529Orig1s011ltr.pdf
09/27/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021529Orig1s010ltr.pdf
06/12/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/03/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf
05/13/2011 SUPPL-7 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021529s007ltr.pdf
02/01/2012 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021529s006ltr.pdf
02/19/2009 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021529s004ltr.pdf
01/18/2007 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021529s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/22/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf
05/19/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021529s015lbl.pdf
03/14/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf
08/19/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf
07/03/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf
09/27/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf
02/01/2012 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf
05/13/2011 SUPPL-7 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf
02/19/2009 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf
07/17/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf

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