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FDA NDA · NDA021320

PLENAXIS

Sponsor: SPECIALITY EUROPEAN

APPLICATION
NDA021320
TYPE
NDA
ORIGINAL APPROVAL
2003-11-25
LATEST ACTION
2005-09-08
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

PLENAXISDiscontinued
ABARELIX 100MG/VIAL · POWDER · INTRAMUSCULAR

Approval history

2005-09-08Labeling · Supplement 2 · priorityLetterAP
2003-11-25Type 1 - New Molecular Entity · Original · priorityLabelAP
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