Application 213311
- Type
- ANDA
- Sponsor
- CSPC OUYI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0832-6022 | Carbamazepine | Carbamazepine | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-6023 | Carbamazepin | Carbamazepine | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-6024 | Carbamazepine | Carbamazepine | Upsher-Smith Laboratories, LLC | ANDA | Current |