USFDA APPLICATION NUMBER - 22304 / DOSAGE - TABLET;ORAL - EQ 100MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
TAPENTADOL(UNII: H8A007M585) (TAPENTADOL - UNII:H8A007M585) | TAPENTADOL | 50mg |
Inactive Ingredients
Ingredient Name | Bryant Ranch Prepack | Janssen Pharmaceuticals, Inc. | Lake Erie Medical DBA Quality Care Products LLC |
---|---|---|---|
aluminum oxide(LMI26O6933) | |||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||
croscarmellose sodium(M28OL1HH48) | |||
lactose monohydrate(EWQ57Q8I5X) | |||
magnesium stearate(70097M6I30) | |||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||
polyethylene glycol(3WJQ0SDW1A) | |||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||
polyethylene glycols(3WJQ0SDW1A) | |||
polyvinyl alcohol(532B59J990) | |||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||
POVIDONE(FZ989GH94E) | |||
POVIDONE, UNSPECIFIED(FZ989GH94E) | |||
talc(7SEV7J4R1U) | |||
titanium dioxide(15FIX9V2JP) |
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