← FDA DRUG APPROVALS

FDA NDA · NDA216099

PHYRAGO

dasatinib

Sponsor: HANDA THERAP

APPLICATION
NDA216099
TYPE
NDA
ORIGINAL APPROVAL
2023-12-05
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PHYRAGO · ReferencePrescription
DASATINIB 100MG · TABLET · ORAL
PHYRAGO · ReferencePrescription
DASATINIB 70MG · TABLET · ORAL
PHYRAGO · ReferencePrescription
DASATINIB 20MG · TABLET · ORAL
PHYRAGO · ReferencePrescription
DASATINIB 140MG · TABLET · ORAL
PHYRAGO · ReferencePrescription
DASATINIB 80MG · TABLET · ORAL
PHYRAGO · ReferencePrescription
DASATINIB 50MG · TABLET · ORAL

Approval history

2025-08-01Efficacy · Supplement 5 · standard — Label ↗AP
2024-12-03Labeling · Supplement 3 · standard — Letter ↗AP
2024-07-31Labeling · Supplement 4 · standard — Letter ↗AP
2023-12-05Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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