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USFDA APPLICATION NUMBER - 21400 / DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| VARDENAFIL HYDROCHLORIDE TRIHYDRATE(UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) | VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 20mg |
Inactive Ingredients
| Ingredient Name | Bryant Ranch Prepack | KAISER FOUNDATION HOSPITALS | PD-Rx Pharmaceuticals, Inc. | GlaxoSmithKline LLC |
|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||
| CROSPOVIDONE(68401960MK) | ||||
| FERRIC OXIDE RED(1K09F3G675) | ||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
| HYPROMELLOSES(3NXW29V3WO) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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