Application 085911
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXYCODONE 5/APAP 500 | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 500MG;5MG | No | No |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A085911-001 | OXYCODONE 5/APAP 500 | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;5MG | TABLET / ORAL | | Approved before 1982 | |