Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021187
Company: ORGANON SUB MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUVARING ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING;VAGINAL 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
10/03/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21187ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/08/2019 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021187s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021187Orig1s037ltr.pdf
12/04/2018 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187s036ltr.pdf
12/04/2018 SUPPL-35 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187s035ltr.pdf
12/04/2017 SUPPL-34 Labeling-Container/Carton Labels Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021187Orig1s034.pdf
08/09/2017 SUPPL-32 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021187Orig1s032ltr.pdf
02/12/2018 SUPPL-31 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021187Orig1s031ltr.pdf
05/30/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021187Orig1s028ltr.pdf
09/30/2016 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021187Orig1s027ltr.pdf
10/31/2014 SUPPL-25 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s025ltr.pdf
06/18/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s024ltr.pdf
07/19/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/04/2013 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf
10/04/2013 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf
02/19/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/29/2008 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021187s018ltr.pdf
10/02/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021187s017ltr.pdf
12/12/2006 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

07/29/2005 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021187s012ltr.pdf
03/02/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr008ltr.pdf
02/04/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr007ltr.pdf
11/05/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/29/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/27/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/08/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021187s037lbl.pdf
12/04/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s036lbl.pdf
12/04/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s035lbl.pdf
12/04/2018 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s035lbl.pdf
02/12/2018 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf
02/12/2018 SUPPL-31 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf
08/09/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf
08/09/2017 SUPPL-32 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s032lbl.pdf
05/30/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021187s028lbl.pdf
09/30/2016 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf
10/31/2014 SUPPL-25 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf
06/18/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf
10/04/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf
10/04/2013 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf
10/02/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf
07/29/2005 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf
10/03/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf

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