Application 021883
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DALVANCE | DALBAVANCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57970-100 | DALVANCE | Dalbavancin | Allergan, Inc. | NDA | Current |
| 57970-100 | DALVANCE | Dalbavancin | Allergan, Inc. | NDA | Current |
| 57970-100 | DALVANCE | Dalbavancin | Durata Therapeutics Inc. | NDA | Current |
| 57970-100 | DALVANCE | Dalbavancin | Allergan, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80854 | SUPPL | 2025-01-15 |
| 80853 | SUPPL | 2025-01-15 |
| 76039 | SUPPL | 2023-11-02 |
| 68176 | SUPPL | 2021-07-26 |
| 68164 | SUPPL | 2021-07-23 |
| 55412 | SUPPL | 2018-09-07 |
| 54994 | SUPPL | 2018-07-26 |
| 16523 | SUPPL | 2016-01-26 |
| 28784 | SUPPL | 2016-01-21 |
| 28783 | SUPPL | 2015-12-22 |
| 24224 | ORIG | 2014-06-25 |
| 21858 | ORIG | 2014-06-25 |
| 16522 | ORIG | 2014-05-27 |
| 6385 | ORIG | 2014-05-27 |