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USFDA APPLICATION NUMBER - 21078 / DOSAGE - TABLET;ORAL - 62.5MG;25MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ATOVAQUONE(UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT) | ATOVAQUONE | 62.5mg |
| PROGUANIL HYDROCHLORIDE(UNII: R71Y86M0WT) (PROGUANIL - UNII:S61K3P7B2V) | PROGUANIL HYDROCHLORIDE | 25mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | Blenheim Pharmacal, Inc. | Clinical Solutions | Clinical Solutions Wholesale | Glenmark Generics Inc | St. Mary's Medical Park Pharmacy | BluePoint Laboratories | PD-Rx Pharmaceuticals, Inc. | Proficient Rx LP |
|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14) | |||||||||
| HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | |||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||
| LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14) | |||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||
| POLOXAMER 188(LQA7B6G8JG) | |||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||
| POVIDONE K30(U725QWY32X) | |||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
