Application 201448
- Type
- ANDA
- Sponsor
- NOSTRUM LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 325MG/5ML;5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29033-405 | Oxycodone Hydrochloride and Acetaminophen | Oxycodone Hydrochloride and Acetaminophen | Nostrum Laboratories, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76477 | ORIG | 2023-11-07 |