Application 207834
- Type
- ANDA
- Sponsor
- ANDA REPOSITORY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;5MG | No | No |
| 002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72022-582 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Halo Pharmaceutical Inc | ANDA | Current |
| 72022-583 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Halo Pharmaceutical Inc | ANDA | Current |
| 72022-584 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Halo Pharmaceutical Inc | ANDA | Current |