APPLICATION
ANDA208554
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-23
LATEST ACTION
2025-01-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
EPTIFIBATIDEPrescription
EPTIFIBATIDE 75MG/100ML · INJECTABLE · INJECTION
EPTIFIBATIDEDiscontinued
EPTIFIBATIDE 2MG/ML · INJECTABLE · INJECTION
Approval history
2025-01-15Labeling · Supplement 4 · standardAP
2018-11-23UNKNOWN · Original · standardAP
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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