Application 090733
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;2.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0603-4978 | Oxycodone and Acetaminophen | Oxycodone hydrochloride and Acetaminophen | Par Pharmaceutical | ANDA | Current |
| 0603-4978 | Oxycodone and Acetaminophen | Oxycodone hydrochloride and Acetaminophen | Par Pharmaceutical | ANDA | Current |
| 0603-4978 | Oxycodone and Acetaminophen | Oxycodone hydrochloride and Acetaminophen | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76173 | ORIG | 2023-11-03 |