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USFDA APPLICATION NUMBER - 201655 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C) | OXYMORPHONE HYDROCHLORIDE | 30mg | 40mg |
Inactive Ingredients
| Ingredient Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | Endo Pharmaceuticals Inc. | SpecGx LLC | Actavis Pharma, Inc. | Quality Care Products, LLC |
|---|---|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL(H4N855PNZ1) | ||||||
| ALPHA-TOCOPHEROL(H4N855PNZ1) | ||||||
| ALUMINUM OXIDE(LMI26O6933) | ||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||||||
| D&C RED NO. 27(2LRS185U6K) | ||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||
| HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI) | ||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||
| POLYVINYL ALCOHOL(532B59J990) | ||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||
| XANTHAN GUM(TTV12P4NEE) |
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