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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218160
Company: ELI LILLY AND CO

Products on NDA 218160

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETEVMO	SELPERCATINIB	40MG	TABLET;ORAL	Prescription	None	Yes	No
RETEVMO	SELPERCATINIB	80MG	TABLET;ORAL	Prescription	None	Yes	No
RETEVMO	SELPERCATINIB	120MG	TABLET;ORAL	Prescription	None	Yes	No
RETEVMO	SELPERCATINIB	160MG	TABLET;ORAL	Prescription	None	Yes	Yes
RETEVMO	SELPERCATINIB	40MG	CAPSULE;ORAL	Prescription	None	No	No
RETEVMO	SELPERCATINIB	80MG	CAPSULE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218160

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218160Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218160Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2024	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218160Orig1s004ltr.pdf
09/27/2024	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218160Orig1s002; s003ltr.pdf
09/27/2024	SUPPL-2	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218160Orig1s002; s003ltr.pdf
06/12/2024	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218160Orig1s001ltr.pdf

Labels for NDA 218160

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s004lbl.pdf
09/27/2024	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s002s003lbl.pdf
09/27/2024	SUPPL-2	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s002s003lbl.pdf
06/12/2024	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s001lbl.pdf
04/10/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s000lbl.pdf

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