Quinine
Drug Details
- Generic Name
- Quinine
- Brand Names
- Quinine Sulfate
- Application Number
- ANDA203729
- Sponsor
- Amneal Pharmaceuticals LLC
- NDC Codes
- 1
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- QUININE SULFATE
Indications and Usage
1 INDICATIONS AND USAGE Quinine Sulfate Capsules, 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 )]. Limitations of Use: Quinine Sulfate is 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, USP is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. ( 1 ) Limitations of Use: Quinine Sulfate is not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps.