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FDA NDA · NDA208715

CABAZITAXEL

Sponsor: SANDOZ

APPLICATION
NDA208715
TYPE
NDA
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
None (Tentative Approval)

Products

CABAZITAXEL · ReferenceNone (Tentative Approval)
CABAZITAXEL 60MG/6ML (10MG/ML) · SOLUTION · INTRAVENOUS
CABAZITAXEL · ReferenceNone (Tentative Approval)
CABAZITAXEL 45MG/4.5ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-10-27Type 3 - New Dosage Form · Original · standardLetterTA
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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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