Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
GlaxoSmithKline LLC
167380711
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atovaquone and Proguanil HCl
Product Details
NDC Product Code
66993-060Application Number
NDA021078Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
February 2, 2021LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
AtovaquoneActive
Code: Y883P1Z2LTClass: ACTIBQuantity: 250 mg in 1 1
ProguanilActive
Code: R71Y86M0WTClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT