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USFDA APPLICATION NUMBER - 200535 / DOSAGE - SOLUTION;ORAL - 100MG/5ML
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 20mg in 1 |
Inactive Ingredients
| Ingredient Name | Lannett Company, Inc. | ANI Pharmaceuticals, Inc. | Lupin Pharmaceuticals, Inc. | Major Pharmaceuticals | Novel Laboratories, Inc. | Roxane Laboratories, Inc. | VistaPharm, Inc. | West-Ward Pharmaceuticals Corp. | KVK-Tech, Inc. | Safecor Health, LLC |
|---|---|---|---|---|---|---|---|---|---|---|
| ACESULFAME POTASSIUM(23OV73Q5G9) | ||||||||||
| ANHYDROUS CITRIC ACID(XF417D3PSL) | ||||||||||
| BERRY(FV3431923Z) | ||||||||||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | ||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||
| EDETATE DISODIUM(7FLD91C86K) | ||||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||||
| GLYCERIN(PDC6A3C0OX) | ||||||||||
| HYDROCHLORIC ACID(QTT17582CB) | ||||||||||
| MALTITOL(D65DG142WK) | ||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||
| SACCHARIN SODIUM(SB8ZUX40TY) | ||||||||||
| SODIUM BENZOATE(OJ245FE5EU) | ||||||||||
| SODIUM CITRATE(1Q73Q2JULR) | ||||||||||
| SODIUM GLUCONATE(R6Q3791S76) | ||||||||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||||||||
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(94255I6E2T) | ||||||||||
| SORBITOL(506T60A25R) | ||||||||||
| SUCRALOSE(96K6UQ3ZD4) | ||||||||||
| TRISODIUM CITRATE DIHYDRATE(B22547B95K) | ||||||||||
| WATER(059QF0KO0R) |
