APPLICATION
ANDA213913
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-12
LATEST ACTION
2024-06-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPOPROSTENOL SODIUMPrescription
EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL · INJECTABLE · INJECTION
EPOPROSTENOL SODIUMPrescription
EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-06-12UNKNOWN · 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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