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FDA NDA · NDA020038

FLUDARA

Sponsor: GENZYME CORP

APPLICATION
NDA020038
TYPE
NDA
ORIGINAL APPROVAL
1991-04-18
LATEST ACTION
2010-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLUDARA · ReferenceDiscontinued
FLUDARABINE PHOSPHATE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2010-07-29Labeling · Supplement 33 · priority — Letter ↗AP
2009-02-10Labeling · Supplement 32 · priority — Letter ↗AP
2007-12-20Labeling · Supplement 31 · priority — Label ↗AP
2003-08-01Efficacy · Supplement 28 · priority — Pediatric Medical Review ↗AP
2002-07-02Manufacturing (CMC) · Supplement 21 · priorityAP
2002-07-02Manufacturing (CMC) · Supplement 22 · priorityAP
2002-05-01Manufacturing (CMC) · Supplement 25 · priorityAP
2002-05-01Manufacturing (CMC) · Supplement 24 · priorityAP
2002-03-28Manufacturing (CMC) · Supplement 23 · priorityAP
2001-12-03Labeling · Supplement 19 · priority — Label ↗AP
2000-03-08Manufacturing (CMC) · Supplement 20 · priorityAP
1999-05-24Labeling · Supplement 17 · priorityAP
1996-09-05Manufacturing (CMC) · Supplement 18 · priorityAP
1996-01-29Manufacturing (CMC) · Supplement 15 · priorityAP
1994-09-26Labeling · Supplement 14 · priorityAP
1993-05-21Manufacturing (CMC) · Supplement 13 · priorityAP
1993-01-07Manufacturing (CMC) · Supplement 7 · priorityAP
1993-01-07Manufacturing (CMC) · Supplement 8 · priorityAP
1992-10-28Labeling · Supplement 11 · priorityAP
1992-04-02Labeling · Supplement 6 · priorityAP
1991-12-04Manufacturing (CMC) · Supplement 5 · priorityAP
1991-12-04Manufacturing (CMC) · Supplement 3 · priorityAP
1991-04-18Type 1 - New Molecular Entity · Original · priority — Pediatric Medical Review ↗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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