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USFDA APPLICATION NUMBER - 21928 / DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| varenicline tartrate(UNII: 82269ASB48) (varenicline - UNII:W6HS99O8ZO) | varenicline | 0.5mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | Cardinal Health | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC |
|---|---|---|---|---|
| anhydrous dibasic calcium phosphate(L11K75P92J) | ||||
| cellulose, microcrystalline(OP1R32D61U) | ||||
| croscarmellose sodium(M28OL1HH48) | ||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
| magnesium stearate(70097M6I30) | ||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
| silicon dioxide(ETJ7Z6XBU4) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||
| TRIACETIN(XHX3C3X673) |
