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USFDA APPLICATION NUMBER - 200533 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| tapentadol hydrochloride(UNII: 71204KII53) (tapentadol - UNII:H8A007M585) | tapentadol | 100mg |
Inactive Ingredients
| Ingredient Name | Janssen Pharmaceuticals, Inc. | Lake Erie Medical DBA Quality Care Products LLC | LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC |
|---|---|---|---|
| .ALPHA.-TOCOPHEROL(H4N855PNZ1) | |||
| ALUMINUM OXIDE(LMI26O6933) | |||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||
| HYPROMELLOSE, UNSPECIFIED (3NXW29V3WO) | |||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||
| hypromelloses(3NXW29V3WO) | |||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||
| polyethylene glycols(3WJQ0SDW1A) | |||
| polyvinyl alcohol(532B59J990) | |||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||
| PROPYLENE GLYCOL (6DC9Q167V3) | |||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||
| SHELLAC (46N107B71O) | |||
| SHELLAC(46N107B71O) | |||
| TALC(7SEV7J4R1U) | |||
| TITANIUM DIOXIDE (15FIX9V2JP) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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