Application 065120
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOBRAMYCIN SULFATE (PHARMACY BULK) | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63323-307 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |