Application 206473
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | LINEZOLID | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
| 0409-4883 | Linezolid | LINEZOLID | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82470 | SUPPL | 2025-06-05 |
| 82362 | SUPPL | 2025-05-30 |
| 80196 | SUPPL | 2024-11-12 |
| 80190 | SUPPL | 2024-11-12 |
| 70209 | SUPPL | 2022-02-22 |
| 70187 | SUPPL | 2022-02-18 |
| 69919 | SUPPL | 2022-01-19 |
| 69911 | SUPPL | 2022-01-19 |
| 68367 | SUPPL | 2021-08-13 |
| 68365 | SUPPL | 2021-08-13 |
| 68262 | SUPPL | 2021-08-02 |
| 68242 | SUPPL | 2021-08-02 |
| 55312 | SUPPL | 2018-08-24 |
| 55274 | SUPPL | 2018-08-23 |
| 50833 | SUPPL | 2017-12-22 |
| 50785 | SUPPL | 2017-12-20 |
| 23021 | ORIG | 2016-07-19 |
| 10573 | ORIG | 2015-06-22 |
| 40550 | ORIG | 2015-06-19 |