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USFDA APPLICATION NUMBER - 204031 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 325mg |
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 7.5mg |
Inactive Ingredients
| Ingredient Name | PD-Rx Pharmaceuticals, Inc. | SpecGx LLC |
|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||
| ANHYDROUS CITRIC ACID(XF417D3PSL) | ||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||
| EDETATE DISODIUM(7FLD91C86K) | ||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||
| HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | ||
| HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||
| POLYETHYLENE GLYCOL 9000(V146K8QJ07) | ||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| STARCH, CORN(O8232NY3SJ) | ||
| TALC(7SEV7J4R1U) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) |
