
USFDA APPLICATION NUMBER - 21110 / DOSAGE - TABLET;ORAL - 0.5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| sirolimus(UNII: W36ZG6FT64) (sirolimus - UNII:W36ZG6FT64) | sirolimus | 1mg |
Inactive Ingredients
| Ingredient Name | American Health Packaging | Cardinal Health |
|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0) | ||
| 1-GLYCERYL MONOOLEATE(D3AEF6S35P) | ||
| ALPHA-TOCOPHEROL(H4N855PNZ1) | ||
| calcium sulfate(WAT0DDB505) | ||
| CARNAUBA WAX(R12CBM0EIZ) | ||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||
| CROSPOVIDONE, UNSPECIFIED(2S7830E561) | ||
| FD&C YELLOW NO. 5(I753WB2F1M) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| GLYCERYL MONOOLEATE(C4YAD5F5G6) | ||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||
| lactose(J2B2A4N98G) | ||
| magnesium stearate(70097M6I30) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLOXAMER 188(LQA7B6G8JG) | ||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
| povidone(FZ989GH94E) | ||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||
| SHELLAC(46N107B71O) | ||
| SUCROSE(C151H8M554) | ||
| TALC(7SEV7J4R1U) | ||
| titanium dioxide(15FIX9V2JP) |