APPLICATION
ANDA206127
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-08
LATEST ACTION
2023-05-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPTIFIBATIDEPrescription
EPTIFIBATIDE 75MG/100ML · INJECTABLE · INJECTION
EPTIFIBATIDEPrescription
EPTIFIBATIDE 2MG/ML · INJECTABLE · INJECTION
Approval history
2023-05-25Labeling · Supplement 4 · standardAP
2015-12-08UNKNOWN · 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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