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FDA NDA · NDA020306

FLUDEOXYGLUCOSE F18

Sponsor: DOWNSTATE CLINCL

APPLICATION
NDA020306
TYPE
NDA
ORIGINAL APPROVAL
1994-08-19
LATEST ACTION
2002-05-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLUDEOXYGLUCOSE F18 · ReferenceDiscontinued
FLUDEOXYGLUCOSE F-18 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
FLUDEOXYGLUCOSE F18 · ReferenceDiscontinued
FLUDEOXYGLUCOSE F-18 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2002-05-15Manufacturing (CMC) · Supplement 7 · priorityAP
2001-09-25Manufacturing (CMC) · Supplement 6 · priorityAP
2000-08-30Manufacturing (CMC) · Supplement 4 · priorityAP
2000-06-02Efficacy · Supplement 5 · standard — Label ↗AP
1999-02-19Manufacturing (CMC) · Supplement 3 · priorityAP
1997-11-05Labeling · Supplement 2 · standardAP
1996-08-13Manufacturing (CMC) · Supplement 1 · priorityAP
1994-08-19Type 1 - New Molecular Entity · Original · priorityAP
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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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