USFDA APPLICATION NUMBER - 207960 / DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49) | METHYLPHENIDATE HYDROCHLORIDE | 40mg | 30mg | 20mg |
Inactive Ingredients
Ingredient Name | NextWave Pharmaceuticals, Inc | NextWave Pharmaceuticals, Inc. |
---|---|---|
ASPARTAME(Z0H242BBR1) | ||
CHERRY(BUC5I9595W) | ||
CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||
D&C RED NO. 30(2S42T2808B) | ||
D&C RED NO. 7(ECW0LZ41X8) | ||
GUAR GUM(E89I1637KE) | ||
MAGNESIUM STEARATE(70097M6I30) | ||
MANNITOL(3OWL53L36A) | ||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
POLYVINYL ACETATE(32K497ZK2U) | ||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||
POVIDONE, UNSPECIFIED(FZ989GH94E) | ||
SILICON DIOXIDE(ETJ7Z6XBU4) | ||
SODIUM POLYSTYRENE SULFONATE(1699G8679Z) | ||
TALC(7SEV7J4R1U) | ||
TRIACETIN(XHX3C3X673) | ||
XANTHAN GUM(TTV12P4NEE) |
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