Application Nr Approved Date Route Status External Links
ANDA091661 2012-09-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Shellac SHELLAC Unresolved
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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