USFDA APPLICATION NUMBER - 20356 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
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) |
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