APPLICATION
ANDA204693
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-07
LATEST ACTION
2025-03-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPTIFIBATIDEPrescription
EPTIFIBATIDE 2MG/ML · INJECTABLE · INJECTION
EPTIFIBATIDEPrescription
EPTIFIBATIDE 75MG/100ML · INJECTABLE · INJECTION
Approval history
2025-03-25Labeling · Supplement 1 · standardAP
2018-03-07UNKNOWN · OriginalAP
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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