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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214846
Company: SUMITOMO PHARMA AM

Products on NDA 214846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYFEMBREE	ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX	1MG;0.5MG;40MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2021	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214846s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214846Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214846Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2025	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214846s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214846Orig1s012ltr.pdf
07/17/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214846s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214846Orig1s008ltr.pdf
04/30/2024	SUPPL-7	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214846s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214846Orig1s007ltr.pdf
01/27/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214846s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214846Orig1s006ltr.pdf
01/27/2023	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214846s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214846Orig1s005ltr.pdf
08/05/2022	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214846s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214846Orig1s002ltr.pdf

Labels for NDA 214846

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2025	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214846s012lbl.pdf
07/17/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214846s008lbl.pdf
04/30/2024	SUPPL-7	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214846s007lbl.pdf
01/27/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214846s006lbl.pdf
01/27/2023	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214846s005lbl.pdf
08/05/2022	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214846s002lbl.pdf
05/26/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214846s000lbl.pdf

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