USFDA APPLICATION NUMBER - 20281 / DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
---|---|---|
tramadol hydrochloride(UNII: 9N7R477WCK) (tramadol - UNII:39J1LGJ30J) | tramadol hydrochloride | 50mg |
Inactive Ingredients
Ingredient Name | A-S Medication Solutions | A-S Medication Solutions LLC | Janssen Pharmaceuticals, Inc. | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. |
---|---|---|---|---|---|
carnauba wax(R12CBM0EIZ) | |||||
cellulose, microcrystalline(OP1R32D61U) | |||||
hypromellose, unspecified(3NXW29V3WO) | |||||
hypromelloses(3NXW29V3WO) | |||||
lactose(J2B2A4N98G) | |||||
lactose, unspecified form(J2B2A4N98G) | |||||
MAGNESIUM STEARATE(70097M6I30) | |||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||
modified corn starch (1-octenyl succinic anhydride)(461P5CJN6T) | |||||
POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||
polyethylene glycol, unspecified(3WJQ0SDW1A) | |||||
polyethylene glycols(3WJQ0SDW1A) | |||||
polysorbate 80(6OZP39ZG8H) | |||||
sodium starch glycolate type a potato(5856J3G2A2) | |||||
starch, corn(O8232NY3SJ) | |||||
titanium dioxide(15FIX9V2JP) |
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