Application 209777
- Type
- NDA
- Sponsor
- INSPIRION DELIVERY
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROXYBOND | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | ROXYBOND | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 003 | ROXYBOND | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 004 | ROXYBOND | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65597-501 | Roxybond | oxycodone hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-501 | Roxybond | oxycodone hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-502 | Roxybond | oxycodone hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-502 | Roxybond | oxycodone hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-503 | Roxybond | oxycodone hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 65597-503 | Roxybond | oxycodone hydrochloride | Daiichi Sankyo Inc. | NDA | Current |
| 81140-101 | RoxyBond | Oxycodone hydrochloride | Protega Pharmaceuticals LLC | NDA | Current |
| 81140-102 | RoxyBond | Oxycodone hydrochloride | Protega Pharmaceuticals LLC | NDA | Current |
| 81140-103 | RoxyBond | Oxycodone hydrochloride | Protega Pharmaceuticals LLC | NDA | Current |