Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206229
Company: MEDICINES360
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LILETTA LEVONORGESTREL 52MG INTRAUTERINE DEVICE;INTRAUTERINE Prescription None No 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
02/26/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206229s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206229Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2020 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206229s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206229Orig1s010ltr.pdf
10/25/2019 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206229s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206229Orig1s008ltr.pdf
10/15/2018 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206229s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206229Orig1s007ltr.pdf
08/03/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206229s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206229Orig1s004ltr.pdf
05/31/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/29/2016 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206229s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206229Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2020 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206229s010lbl.pdf
10/25/2019 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206229s008lbl.pdf
10/15/2018 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206229s007lbl.pdf
08/03/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206229s004lbl.pdf
01/29/2016 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206229s001lbl.pdf
02/26/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206229s000lbl.pdf

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