Application 050789
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-303 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-303 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-303 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-303 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-303 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73471 | SUPPL | 2023-02-13 |
| 73462 | SUPPL | 2023-02-13 |
| 67097 | SUPPL | 2021-04-19 |
| 67090 | SUPPL | 2021-04-19 |
| 62461 | SUPPL | 2020-04-07 |
| 62454 | SUPPL | 2020-04-06 |
| 8293 | SUPPL | 2009-11-27 |
| 39337 | SUPPL | 2009-09-22 |
| 42739 | ORIG | 2006-10-25 |
| 39336 | ORIG | 2004-07-21 |
| 30547 | ORIG | 2004-07-21 |