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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021529
Company: ORGANON
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/24/2020 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021529s019s020lbl.pdf
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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