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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216099
Company: HANDA THERAP

Products on NDA 216099

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHYRAGO	DASATINIB	20MG	TABLET;ORAL	Prescription	None	Yes	No
PHYRAGO	DASATINIB	50MG	TABLET;ORAL	Prescription	None	Yes	No
PHYRAGO	DASATINIB	70MG	TABLET;ORAL	Prescription	None	Yes	No
PHYRAGO	DASATINIB	80MG	TABLET;ORAL	Prescription	None	Yes	No
PHYRAGO	DASATINIB	100MG	TABLET;ORAL	Prescription	None	Yes	Yes
PHYRAGO	DASATINIB	140MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216099

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216099s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216099Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216099Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2025	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216099s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216099Orig1s005ltr.pdf
07/31/2024	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216099s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216099Orig1s004ltr.pdf
12/03/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216099s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216099Orig1s003ltr.pdf

Labels for NDA 216099

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2025	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216099s005lbl.pdf
12/03/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216099s003lbl.pdf
07/31/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216099s004lbl.pdf
12/05/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216099s000lbl.pdf

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