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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206229
Company: MEDICINES360

Products on NDA 206229

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LILETTA	LEVONORGESTREL	52MG	INTRAUTERINE DEVICE;INTRAUTERINE	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206229

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/2015/206229Orig1s000ltr.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
06/29/2023	SUPPL-13	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206229s013lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206229Orig1s013ltr.pdf
11/10/2022	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206229s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206229Orig1s011,s012ltr.pdf
11/10/2022	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206229s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206229Orig1s011,s012ltr.pdf
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

Labels for NDA 206229

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/29/2023	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206229s013lbledt.pdf
11/10/2022	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206229s011s012lbl.pdf
11/10/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206229s011s012lbl.pdf
11/10/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206229s011s012lbl.pdf
11/10/2022	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206229s011s012lbl.pdf
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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