Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atovaquone and Proguanil Hydrochloride
Product Details
NDC Product Code
54868-6393Application Number
ANDA091211Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 12, 2013ProguanilActive
Code: R71Y86M0WTClass: ACTIBQuantity: 100 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
AtovaquoneActive
Code: Y883P1Z2LTClass: ACTIBQuantity: 250 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT