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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208224
Company: BAYER HLTHCARE

Products on NDA 208224

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208224

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
05/04/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208224s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208224Orig1s005ltr.pdf
01/10/2022	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208224s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208224Orig1s004ltr.pdf
04/13/2021	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	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, Labeling-Package Insert, Labeling-Patient Package Insert	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

Labels for NDA 208224

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208224s005lbl.pdf
01/10/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208224s004lbl.pdf
04/13/2021	SUPPL-2	Labeling-Container/Carton Labels	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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208224Orig1s002lbl.pdf
03/01/2018	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208224s001lbl.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
09/16/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208224s000lbl.pdf

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