Atovaquone and Proguanil Hydrochloride

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

0378-4160

Application Number

ANDA202362

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 21, 2019

Ingredients

AtovaquoneActive

Code: Y883P1Z2LTClass: ACTIBQuantity: 62.5 mg in 1 1

ProguanilActive

Code: R71Y86M0WTClass: ACTIBQuantity: 25 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JGClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT