Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208224
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KYLEENA LEVONORGESTREL 19.5MG 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
09/16/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208224s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208224Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208224Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2021 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208224Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208224Orig1s002Advice_ltr2.pdf
03/01/2018 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208224s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203159Orig1s010,208224Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/13/2021 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208224Orig1s002lbl.pdf
04/13/2021 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208224Orig1s002lbl.pdf
04/13/2021 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208224Orig1s002lbl.pdf
03/01/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208224s001lbl.pdf
03/01/2018 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208224s001lbl.pdf
03/01/2018 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208224s001lbl.pdf
09/16/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208224s000lbl.pdf

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