
USFDA APPLICATION NUMBER - 201194 / DOSAGE - SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 5mg in 5 | 5mg in 5 |
Inactive Ingredients
| Ingredient Name | VistaPharm, Inc. |
|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| GLYCERIN(PDC6A3C0OX) | |
| POLOXAMER 188(LQA7B6G8JG) | |
| SODIUM BENZOATE(OJ245FE5EU) | |
| SORBITOL(506T60A25R) | |
| WATER(059QF0KO0R) |