Application Nr Approved Date Route Status External Links
BLA018780 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Humulin R U-500 Is A Concentrated Human Insulin Indicated To Improve Glycemic Control In Adult And Pediatric Patients With Diabetes Mellitus Requiring More Than 200 Units Of Insulin Per Day. Humulin ® R U-500 Is A Concentrated Human Insulin Indicated To Improve Glycemic Control In Adults And Children With Diabetes Mellitus Requiring More Than 200 Units Of Insulin Per Day. ( 1 ) Limitation Of Use: The Safety And Efficacy Of Humulin R U-500 Used In Combination With Other Insulins Has Not Been Determined. The Safety And Efficacy Of Humulin R U-500 Delivered By Continuous Subcutaneous Infusion Has Not Been Determined. ( 1.1 ) 1.1 Limitation Of Use The Safety And Efficacy Of Humulin R U-500 Used In Combination With Other Insulins Has Not Been Determined. The Safety And Efficacy Of Humulin R U-500 Delivered By Continuous Subcutaneous Infusion Has Not Been Determined.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Insulin Human

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