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FDA NDA · NDA209191

BORTEZOMIB

Sponsor: HOSPIRA

APPLICATION
NDA209191
TYPE
NDA
ORIGINAL APPROVAL
2022-05-02
LATEST ACTION
2022-12-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

BORTEZOMIB · ReferencePrescription
BORTEZOMIB 1MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS
BORTEZOMIB · ReferencePrescription
BORTEZOMIB 2.5MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS

Approval history

2022-12-09Efficacy · Supplement 3 · standard — Label ↗AP
2022-05-02Type 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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