Application Nr Approved Date Route Status External Links
ANDA206561 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Indomethacin For Injection Is Indicated To Close A Hemodynamically Significant Patent Ductus Arteriosus In Premature Infants Weighing Between 500 And 1750 G When After 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 And Pulmonary Plethora On Chest X-Ray.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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