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FDA NDA · NDA215441

BORTEZOMIB

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA215441
TYPE
NDA
ORIGINAL APPROVAL
2022-07-26
LATEST ACTION
2022-07-26
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

BORTEZOMIB · ReferenceDiscontinued
BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
BORTEZOMIB · ReferenceDiscontinued
BORTEZOMIB 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2022-07-26Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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