Application Nr Approved Date Route Status External Links
ANDA203112 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Quinine Sulfate Capsule Usp Is A Cinchona Alkaloid Indicated For Treatment Of Uncomplicated Plasmodium Falciparum Malaria ( 1 ). Quinine Sulfate Capsule Usp 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 )] . Quinine Sulfate Capsules Usp 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 )] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments