Application 211499
- Type
- ANDA
- Sponsor
- ABHAI LLC
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 | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10702-238 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | KVK-Tech, Inc. | ANDA | Current |
| 10702-238 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | KVK-Tech, Inc. | ANDA | Current |
| 10702-238 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen | KVK-Tech, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76433 | ORIG | 2023-11-07 |