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FDA NDA · NDA022072

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APPLICATION
NDA022072
TYPE
NDA
ORIGINAL APPROVAL
2006-06-28
LATEST ACTION
2010-07-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SPRYCELPrescription
DASATINIB 70MG · TABLET · ORAL

Approval history

2010-07-28Labeling · Supplement 2 · standardLetterAP
2008-05-30Manufacturing (CMC) · Supplement 1LetterAP
2006-06-28Type 6 - New Indication (no longer used) · Original · priorityReviewAP
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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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