Application Nr Approved Date Route Status External Links
ANDA203729 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Quinine Sulfate Is An Antimalarial Drug Indicated Only For Treatment Of Uncomplicated Plasmodium Falciparum Malaria. Quinine Sulfate Has Been Shown To Be Effective In Geographical Regions Where Resistance To Chloroquine Has Been Documented [See Clinical Studies (14) ] . Limitations Of Use: Quinine Sulfate Capsules Are Not Approved For: Treatment Of Severe Or Complicated P. Falciparum Malaria. Prevention Of Malaria. Treatment Or Prevention Of Nocturnal Leg Cramps [See Warnings And Precautions (5.1) ] . Quinine Sulfate Is An Antimalarial Indicated For Treatment Of Uncomplicated Plasmodium Falciparum Malaria. (1) Limitations Of Use: Quinine Sulfate Capsules Are Not Approved For: Treatment Of Severe Or Complicated P. Falciparum Malaria. Prevention Of Malaria. Treatment Or Prevention Of Nocturnal Leg Cramps

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Quinine Sulfate QUININE SULFATE ZINC3831404

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