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FDA NDA · NDA022137

FLUDARABINE PHOSPHATE

Sponsor: CAPLIN ONE LABS

APPLICATION
NDA022137
TYPE
NDA
ORIGINAL APPROVAL
2007-09-21
LATEST ACTION
2024-11-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLUDARABINE PHOSPHATE · ReferenceDiscontinued
FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-11-19Efficacy · Supplement 15 · standard — Label ↗AP
2016-05-17Manufacturing (CMC) · Supplement 13 · standardAP
2016-05-10Manufacturing (CMC) · Supplement 9 · standardAP
2015-11-12Manufacturing (CMC) · Supplement 12 · standardAP
2014-09-29Manufacturing (CMC) · Supplement 10 · standardAP
2014-03-25Manufacturing (CMC) · Supplement 7 · standardAP
2014-03-25Manufacturing (CMC) · Supplement 5 · standardAP
2014-03-25Manufacturing (CMC) · Supplement 6 · standardAP
2011-02-18Labeling · Supplement 3 · standard — Label ↗AP
2007-09-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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