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FDA NDA · NDA218197

TRUQAP

capivasertib

Sponsor: ASTRAZENECA

APPLICATION
NDA218197
TYPE
NDA
ORIGINAL APPROVAL
2023-11-16
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRUQAP · ReferencePrescription
CAPIVASERTIB 200MG · TABLET · ORAL
TRUQAP · ReferencePrescription
CAPIVASERTIB 160MG · TABLET · ORAL

Approval history

2026-06-12Efficacy · Supplement 4 · standard — Letter ↗AP
2026-05-27Labeling · Supplement 5 · standard — Letter ↗AP
2025-11-14Labeling · Supplement 3 · standard — Label ↗AP
2025-02-13Labeling · Supplement 2 · standard — Letter ↗AP
2024-09-23Labeling · Supplement 1 · standard — Label ↗AP
2023-11-16Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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