← FDA DRUG APPROVALS

FDA NDA · NDA219921

KYXATA

carboplatin

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA219921
TYPE
NDA
ORIGINAL APPROVAL
2025-08-08
LATEST ACTION
2025-08-08
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

KYXATA · ReferencePrescription
CARBOPLATIN 500MG/50ML (10MG/ML) · SOLUTION · INTRAVENOUS
KYXATA · ReferenceDiscontinued
CARBOPLATIN 20MG/2ML (10MG/ML) · SOLUTION · INTRAVENOUS
KYXATA · ReferencePrescription
CARBOPLATIN 80MG/8ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-08-08Type 5 - New Formulation or New Manufacturer · Original · standard — 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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