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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214665
Company: AMGEN INC

Products on NDA 214665

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMAKRAS	SOTORASIB	120MG	TABLET;ORAL	Prescription	None	Yes	No
LUMAKRAS	SOTORASIB	320MG	TABLET;ORAL	Prescription	None	Yes	Yes
LUMAKRAS	SOTORASIB	240MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214665Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214665Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214665s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214665Orig1s012ltr.pdf
01/16/2025	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214665Orig1s009correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214665Orig1s009correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214665Orig1s009.pdf
03/17/2023	SUPPL-7	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s007ltr.pdf
04/24/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s004ltr.pdf
01/20/2023	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s003ltr.pdf
11/21/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214665s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214665Orig1s002ltr.pdf

Labels for NDA 214665

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2025	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214665Orig1s009correctedlbl.pdf
09/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214665s012lbl.pdf
04/24/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf
01/20/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf
01/20/2023	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf
11/21/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214665s002lbl.pdf
05/28/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf

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