APPLICATION
ANDA078396
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-23
LATEST ACTION
2022-06-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
EPOPROSTENOL SODIUMDiscontinued
EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL · INJECTABLE · INJECTION
EPOPROSTENOL SODIUMDiscontinued
EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2022-06-09Labeling · Supplement 22 · standardAP
2022-06-09Labeling · Supplement 23 · standardAP
2022-06-09Labeling · Supplement 21 · standardAP
2015-04-29Labeling · Supplement 10AP
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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