APPLICATION
ANDA078687
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-23
LATEST ACTION
2010-09-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ENALAPRILATPrescription
ENALAPRILAT 1.25MG/ML · INJECTABLE · INJECTION
Approval history
2010-09-27Labeling · Supplement 7AP
2010-04-29Labeling · Supplement 6AP
2008-12-23OriginalAP
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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