Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203159
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SKYLA LEVONORGESTREL 13.5MG 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
01/09/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159_skyla_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2018 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203159s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203159Orig1s010,208224Orig1s001ltr.pdf
12/21/2016 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s008ltr.pdf
03/03/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203159s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203159Orig1s007ltr.pdf
11/02/2016 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s006ltr.pdf
04/08/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s005ltr.pdf
05/08/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/13/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s002lbledt1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s002ltredt1.pdf
08/07/2013 SUPPL-1 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s001lbledt1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s001ltredt1.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/01/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203159s010lbl.pdf
03/01/2018 SUPPL-10 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203159s010lbl.pdf
03/03/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203159s007lbl.pdf
12/21/2016 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s008lbl.pdf
11/02/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s006lbl.pdf
04/08/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s005lbl.pdf
09/13/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s002lbledt1.pdf
08/07/2013 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s001lbledt1.pdf
01/09/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s000lbl.pdf

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