Application 207574
- Type
- ANDA
- Sponsor
- XIROMED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70700-105 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Xiromed, LLC | ANDA | Current |
| 70700-105 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Xiromed, LLC | ANDA | Current |
| 70700-105 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Xiromed, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76058 | ORIG | 2023-11-02 |