
USFDA APPLICATION NUMBER - 20356 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 34MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| NISOLDIPINE(UNII: 4I8HAB65SZ) (NISOLDIPINE - UNII:4I8HAB65SZ) | NISOLDIPINE | 34mg | 17mg | 8.5mg |
Inactive Ingredients
| Ingredient Name | Shionogi Inc. |
|---|---|
| CARNAUBA WAX(R12CBM0EIZ) | |
| FD&C YELLOW NO. 5(I753WB2F1M) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| GLYCERYL DIBEHENATE(R8WTH25YS2) | |
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR) | |
| HYPROMELLOSES(3NXW29V3WO) | |
| LACTOSE(J2B2A4N98G) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577) | |
| POLYDEXTROSE(VH2XOU12IE) | |
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |
| POVIDONES(FZ989GH94E) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| SODIUM LAURYL SULFATE(368GB5141J) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |