Application Nr Approved Date Route Status External Links
NDA022536 2010-03-17 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Indomethacin For Injection Is Indicated To Close A Hemodynamically Significant Patent Ductus Arteriosus In Premature Infants Weighing Between 500 And 1,750 G When 48 Hours Usual Medical Management (e.g., Fluid Restriction, Diuretics, Digitalis, Respiratory Support, Etc.) Is Ineffective. Clear-Cut Clinical Evidence Of A Hemodynamically Significant Patent Ductus Arteriosus Should Be Present, Such As Respiratory Distress, A Continuous Murmur, A Hyperactive Precordium, Cardiomegaly, Or Pulmonary Plethora On Chest X-Ray. Indomethacin For Injection Is A Cardiovascular Drug Indicated: To Close A Hemodynamically Significant Patent Ductus Arteriosus In Premature Infants Weighing Between 500 And 1,750 G. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indomethacin INDOMETHACIN ZINC601283

Comments