Application 076697
- Type
- ANDA
- Sponsor
- NOSTRUM LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29033-004 | Carbamazepine | carbamazepine | Nostrum Laboratories, Inc. | ANDA | Current |
| 29033-004 | Carbamazepine | Carbamazepine | Nostrum Laboratories, Inc. | ANDA | Current |
| 29033-019 | Carbamazepine | carbamazepine | Nostrum Laboratories, Inc. | ANDA | Current |
| 29033-020 | Carbamazepine | carbamazepine | Nostrum Laboratories, Inc. | ANDA | Current |