Application 050609
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYTHROCIN | ERYTHROMYCIN LACTOBIONATE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Yes | Yes |
| 002 | ERYTHROCIN | ERYTHROMYCIN LACTOBIONATE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-6482 | Erythrocin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Hospira, Inc. | NDA | Current |
| 0409-6482 | Erythrocin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Hospira, Inc. | NDA | Current |
| 0409-6482 | Erythrocin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Hospira, Inc. | NDA | Current |
| 0409-6482 | Erythrocin Lactobionate | ERYTHROMYCIN LACTOBIONATE | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72670 | SUPPL | 2022-11-22 |
| 72657 | SUPPL | 2022-11-20 |
| 62162 | SUPPL | 2020-03-17 |
| 60790 | SUPPL | 2019-11-07 |
| 53812 | SUPPL | 2018-04-24 |
| 53800 | SUPPL | 2018-04-24 |
| 7883 | SUPPL | 2013-08-22 |
| 17928 | SUPPL | 2013-08-21 |
| 39037 | SUPPL | 2012-02-06 |
| 30165 | SUPPL | 2012-02-06 |
| 17927 | SUPPL | 2011-06-16 |
| 7882 | SUPPL | 2011-06-13 |
| 7881 | SUPPL | 2008-02-29 |
| 17926 | SUPPL | 2008-02-28 |
| 30164 | SUPPL | 2004-09-17 |
| 30163 | SUPPL | 2002-05-23 |