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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203159
Company: BAYER HLTHCARE

Summary Review

Products on NDA 203159

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203159

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
05/04/2023	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203159s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203159Orig1s014ltr.pdf
01/12/2022	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203159s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203159Orig1s013ltr.pdf
05/17/2021	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203159s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203159Orig1s012ltr.pdf
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

Labels for NDA 203159

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203159s014lbl.pdf
01/12/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203159s013lbl.pdf
05/17/2021	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203159s012lbl.pdf
05/17/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203159s012lbl.pdf
05/17/2021	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203159s012lbl.pdf
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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