Application 206334
- Type
- NDA
- Sponsor
- MELINTA THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORBACTIV | ORITAVANCIN DIPHOSPHATE | POWDER;INTRAVENOUS | EQ 400MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65293-015 | Orbactiv | oritavancin | The Medicines Company | NDA | Current |
| 65293-015 | Orbactiv | oritavancin | The Medicines Company | NDA | Current |
| 65293-015 | Orbactiv | oritavancin | The Medicines Company | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, Inc. | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, LLC | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, Inc. | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, LLC | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, Inc. | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, LLC | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, LLC | NDA | Current |
| 70842-140 | Orbactiv | oritavancin | Melinta Therapeutics, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69931 | SUPPL | 2022-01-20 |
| 69897 | SUPPL | 2022-01-18 |
| 68201 | SUPPL | 2021-07-27 |
| 68187 | SUPPL | 2021-07-26 |
| 61257 | SUPPL | 2019-12-12 |
| 61254 | SUPPL | 2019-12-12 |
| 53492 | SUPPL | 2018-03-28 |
| 53250 | SUPPL | 2018-03-23 |
| 47277 | SUPPL | 2017-02-22 |
| 45561 | SUPPL | 2016-10-19 |
| 40540 | SUPPL | 2016-01-26 |
| 10562 | SUPPL | 2016-01-21 |
| 44944 | ORIG | 2014-09-05 |
| 43519 | ORIG | 2014-09-05 |
| 19716 | ORIG | 2014-08-08 |
| 32799 | ORIG | 2014-08-07 |