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USFDA APPLICATION NUMBER - 17443 / DOSAGE - CAPSULE;ORAL - 25MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| DANTROLENE SODIUM(UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR) | DANTROLENE SODIUM | 50mg | 25mg |
Inactive Ingredients
| Ingredient Name | Amneal Pharmaceuticals of New York LLC | Avera McKennan Hospital | Par Pharmaceutical, Inc. |
|---|---|---|---|
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||
| FD&C GREEN NO. 3(3P3ONR6O1S) | |||
| FD&C RED NO. 40(WZB9127XOA) | |||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||
| FERRIC OXIDE RED(1K09F3G675) | |||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||
| GELATIN(2G86QN327L) | |||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| STARCH, CORN(O8232NY3SJ) | |||
| TALC(7SEV7J4R1U) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) |
