Application 202116
- Type
- ANDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-263 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-263 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-263 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-263 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-263 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-264 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-264 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-264 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-264 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-264 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-265 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-265 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-265 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-265 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 47781-265 | Oxycodone hydrochloride | Oxycodone hydrochloride | Alvogen, Inc. | ANDA | Current |
| 68071-2536 | Oxycodone hydrochloride | Oxycodone hydrochloride | NuCare Pharmaceuticals,Inc, | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76328 | ORIG | 2023-11-03 |