Application 022110
- Type
- NDA
- Sponsor
- CUMBERLAND PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIBATIV | TELAVANCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 250MG BASE/VIAL | Yes | No |
| 002 | VIBATIV | TELAVANCIN HYDROCHLORIDE | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52118-001 | Vibativ | telavancin hydrochloride | Theravance, Inc. | NDA | Current |
| 52118-002 | Vibativ | telavancin hydrochloride | Theravance, Inc. | NDA | Current |
| 62847-001 | Vibativ | telavancin hydrochloride | Theravance Biopharma R&D, Inc. | NDA | Current |
| 62847-001 | Vibativ | telavancin hydrochloride | Theravance Biopharma R&D, Inc. | NDA | Current |
| 62847-001 | Vibativ | telavancin hydrochloride | Theravance Biopharma R&D, Inc. | NDA | Current |
| 62847-001 | Vibativ | telavancin hydrochloride | Theravance Biopharma R&D, Inc. | NDA | Current |
| 62847-002 | Vibativ | telavancin hydrochloride | Theravance Biopharma R&D, Inc. | NDA | Current |
| 66220-315 | VIBATIV | telavancin hydrochloride | Cumberland Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63828 | SUPPL | 2020-07-08 |
| 63823 | SUPPL | 2020-07-08 |
| 61939 | SUPPL | 2020-02-21 |
| 61930 | SUPPL | 2020-02-21 |
| 48549 | SUPPL | 2017-05-26 |
| 16961 | SUPPL | 2016-05-09 |
| 6910 | SUPPL | 2016-05-09 |
| 24017 | SUPPL | 2016-03-29 |
| 6911 | SUPPL | 2016-03-25 |
| 16960 | SUPPL | 2014-12-10 |
| 6909 | SUPPL | 2014-12-04 |
| 6908 | SUPPL | 2014-11-14 |
| 16959 | SUPPL | 2014-03-19 |
| 16958 | SUPPL | 2014-02-10 |
| 6907 | SUPPL | 2013-06-26 |
| 16957 | SUPPL | 2013-06-25 |
| 29265 | SUPPL | 2011-07-27 |
| 44681 | ORIG | 2009-11-25 |
| 42418 | ORIG | 2009-11-25 |
| 23358 | ORIG | 2009-09-25 |
| 38262 | ORIG | 2009-09-18 |
| 29264 | ORIG | 2009-09-16 |