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USFDA APPLICATION NUMBER - 21110 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| sirolimus(UNII: W36ZG6FT64) (sirolimus - UNII:W36ZG6FT64) | sirolimus | 1mg |
Inactive Ingredients
| Ingredient Name | Cardinal Health |
|---|---|
| 1-GLYCERYL MONOOLEATE(D3AEF6S35P) | |
| ALPHA-TOCOPHEROL(H4N855PNZ1) | |
| calcium sulfate(WAT0DDB505) | |
| CARNAUBA WAX(R12CBM0EIZ) | |
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |
| lactose(J2B2A4N98G) | |
| magnesium stearate(70097M6I30) | |
| POLOXAMER 188(LQA7B6G8JG) | |
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | |
| povidone(FZ989GH94E) | |
| SHELLAC(46N107B71O) | |
| sucrose(C151H8M554) | |
| talc(7SEV7J4R1U) | |
| titanium dioxide(15FIX9V2JP) |
