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USFDA APPLICATION NUMBER - 201194 / DOSAGE - SOLUTION;ORAL - 5MG/5ML
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 5mg in 5 | 5mg in 5 |
Inactive Ingredients
| Ingredient Name | Morton Grove Pharmaceuticals, Inc. | Roxane Laboratories, Inc. | VistaPharm, Inc. | KVK-Tech, Inc. | Safecor Health, LLC |
|---|---|---|---|---|---|
| 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) | |||||
| GLYCERIN(PDC6A3C0OX) | |||||
| HYDROCHLORIC ACID(QTT17582CB) | |||||
| MALTITOL(D65DG142WK) | |||||
| POLOXAMER 188(LQA7B6G8JG) | |||||
| SACCHARIN SODIUM(SB8ZUX40TY) | |||||
| SODIUM BENZOATE(OJ245FE5EU) | |||||
| SODIUM CITRATE(1Q73Q2JULR) | |||||
| SODIUM HYDROXIDE(55X04QC32I) | |||||
| SORBITOL(506T60A25R) | |||||
| SUCRALOSE(96K6UQ3ZD4) | |||||
| WATER(059QF0KO0R) |
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