Basic Information
Atovaquone and Proguanil Hydrochloride
51407-869
Regulatory Information
51407-869
ANDA202362
C73584
April 2, 2024
USA
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS. These highlights do not include all the information needed to use ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS. ATOVAQUONE and PROGUANIL HYDROCHLORIDE tablets, for oral use ATOVAQUONE and PROGUANIL HYDROCHLORIDE pediatric tablets, for oral use Initial U.S. Approval: 2000
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
603184490
Active Ingredients
Inactive Ingredients
CROSPOVIDONE, UNSPECIFIED
Code: 2S7830E561
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POLOXAMER 188
Code: LQA7B6G8JG
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
Active Moieties
ATOVAQUONE
Code: Y883P1Z2LT
PROGUANIL
Code: S61K3P7B2V