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USFDA APPLICATION NUMBER - 21151 / DOSAGE - TABLET;ORAL - 80MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| SOTALOL HYDROCHLORIDE(UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I) | SOTALOL HYDROCHLORIDE | 160mg | 120mg | 80mg |
Inactive Ingredients
| Ingredient Name | Avera McKennan Hospital | Impax Generics | Eon Labs, Inc. | Mylan Pharmaceuticals Inc. | PD-Rx Pharmaceuticals, Inc. | Apotex Corp. | AvKARE, Inc. | Bryant Ranch Prepack | Golden State Medical Supply, Inc. | Lake Erie Medical DBA Quality Care Products LLC | NCS HealthCare of KY, Inc dba Vangard Labs | NuCare Pharmaceuticals, Inc. | Par Pharmaceutical | Bayer HealthCare Pharmaceuticals Inc. | Proficient Rx LP | Cardinal Health |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||||||||||||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||||||||||
| cellulose, microcrystalline(OP1R32D61U) | ||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||||||||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||||||||||||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||||||||||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | ||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||||
| POVIDONE K30(U725QWY32X) | ||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||||||||
| STEARIC ACID(4ELV7Z65AP) |
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