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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213721
Company: RIGEL PHARMS

Products on NDA 213721

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GAVRETO	PRALSETINIB	100MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213721Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2024	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213721Orig1s015ltr.pdf
07/20/2023	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213721Orig1s014ltr.pdf
06/30/2023	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213721Orig1s011ltr.pdf
08/09/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213721Orig1s009ltr.pdf
09/28/2022	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s007lbl.pdf
02/02/2022	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213721Orig1s005ltr.pdf
11/10/2021	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213721Orig1s004ltr.pdf
09/04/2020	SUPPL-1		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213721s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213721Orig1s000ltr.pdf

Labels for NDA 213721

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf
08/09/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf
07/20/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s014lbl.pdf
06/30/2023	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s011lbl.pdf
06/30/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s011lbl.pdf
09/28/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s007lbl.pdf
09/28/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s007lbl.pdf
02/02/2022	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213721s005lbl.pdf
11/10/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf
11/10/2021	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf
11/10/2021	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf
09/04/2020	SUPPL-1	Type 1 - New Molecular Entity	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213721s000lbl.pdf

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