USFDA APPLICATION NUMBER - 21217 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06) | HYDROMORPHONE HYDROCHLORIDE | 16mg |
Inactive Ingredients
Ingredient Name | Lake Erie Medical DBA Quality Care Products LLC | Physicians Total Care, Inc. | SpecGx LLC | STAT Rx USA LLC |
---|---|---|---|---|
ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | ||||
CELLULOSE ACETATE(3J2P07GVB6) | ||||
FERRIC OXIDE RED(1K09F3G675) | ||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
FERROSOFERRIC OXIDE(XM0M87F357) | ||||
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||
LACTOSE, ANHYDROUS(3SY5LH9PMK) | ||||
MAGNESIUM STEARATE(70097M6I30) | ||||
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||
POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||
POVIDONE(FZ989GH94E) | ||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||
POVIDONES(FZ989GH94E) | ||||
SODIUM CHLORIDE(451W47IQ8X) | ||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||
TRIACETIN(XHX3C3X673) |
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