Application Nr Approved Date Route Status External Links
NDA204630 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Provayblue ® Usp Is Indicated For The Treatment Of Pediatric And Adult Patients With Acquired Methemoglobinemia. This Indication Is Approved Under Accelerated Approval. Continued Approval For This Indication May Be Contingent Upon Verification Of Clinical Benefit In Subsequent Trials [ See Clinical Studies ( 14.1 ) ]. Provayblue ® (Methylene Blue) Is An Oxidation-Reduction Agent Indicated For The Treatment Of Pediatric And Adult Patients With Acquired Methemoglobinemia. This Indication Is Approved Under Accelerated Approval. Continued Approval For This Indication May Be Contingent Upon Verification Of Clinical Benefit In Subsequent Trials. ( 1 , 14 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methylene Blue

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