Application 206030
- Type
- NDA
- Sponsor
- LUNDBECK PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARNEXIV | CARBAMAZEPINE | SOLUTION;INTRAVENOUS | 200MG/20ML (10MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67386-621 | CARNEXIV | Carbamazepine | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-621 | CARNEXIV | Carbamazepine | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-621 | CARNEXIV | Carbamazepine | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-621 | CARNEXIV | Carbamazepine | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-621 | CARNEXIV | Carbamazepine | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-621 | CARNEXIV | Carbamazepine | Lundbeck Pharmaceuticals LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61267 | SUPPL | 2019-12-13 |
| 61264 | SUPPL | 2019-12-13 |
| 50467 | ORIG | 2017-11-21 |
| 45609 | ORIG | 2016-10-12 |
| 45521 | ORIG | 2016-10-12 |