APPLICATION
ANDA213081
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-07
LATEST ACTION
2022-04-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPTIFIBATIDEPrescription
EPTIFIBATIDE 75MG/100ML · INJECTABLE · INJECTION
EPTIFIBATIDEPrescription
EPTIFIBATIDE 2MG/ML · INJECTABLE · INJECTION
Approval history
2022-04-20Manufacturing (CMC) · Supplement 1 · unknownAP
2021-09-07UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.