USFDA APPLICATION NUMBER - 200533 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG 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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