Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021225
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRENA LEVONORGESTREL 52MG INTRAUTERINE DEVICE;INTRAUTERINE 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
12/06/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-225_Mirena.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021225Orig1S039ltr.pdf
06/08/2017 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021225Orig1s038ltr.pdf
12/21/2016 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021225s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/21225Orig1s037ltr.pdf
12/08/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/08/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/29/2014 SUPPL-33 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021225s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021225Orig1s033.pdf
08/07/2013 SUPPL-32 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021225s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021225Orig1s032_correctionltr.pdf
10/22/2015 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021225s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021225Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021225Orig1s031.pdf
03/07/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/01/2009 SUPPL-27 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021225s027ltr.pdf
07/21/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s019ltr.pdf
06/02/2008 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s018ltr.pdf
05/28/2008 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s017ltr.pdf
08/27/2003 SUPPL-10 Manufacturing (CMC)-Expiration Date Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21225sce010ltr.pdf
01/08/2004 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21225slr009ltr.pdf
11/27/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/12/2001 SUPPL-2 Labeling

Label is not available on this site.

10/29/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/08/2017 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s038lbl.pdf
05/25/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021225s039lbl.pdf
12/21/2016 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021225s037lbl.pdf
10/22/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021225s031lbl.pdf
05/29/2014 SUPPL-33 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021225s033lbl.pdf
08/07/2013 SUPPL-32 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021225s032lbl.pdf
10/01/2009 SUPPL-27 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf
07/21/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf

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