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FDA NDA · NDA215813

DOCIVYX

docetaxel

Sponsor: AVYXA HOLDINGS

APPLICATION
NDA215813
TYPE
NDA
ORIGINAL APPROVAL
2022-11-22
LATEST ACTION
2025-01-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE, SOLUTION
MARKETING STATUS
Prescription

Products

DOCETAXELPrescription
DOCETAXEL 160MG/16ML · INJECTABLE · INJECTION
DOCIVYX · ReferencePrescription
DOCETAXEL 80MG/8ML (10MG/ML) · SOLUTION · INTRAVENOUS
DOCIVYX · ReferencePrescription
DOCETAXEL 160MG/16ML (10MG/ML) · SOLUTION · INTRAVENOUS
DOCIVYX · ReferencePrescription
DOCETAXEL 20MG/2ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-01-17Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2024-04-11Labeling · Supplement 1 · standard — Label ↗AP
2024-04-11Labeling · Supplement 2 · standard — Label ↗AP
2022-11-22Type 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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