Application 065122
- Type
- ANDA
- 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 10MG BASE/ML | No | No |
| 002 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-305 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-305 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-305 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-306 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-306 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-306 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-306 | Tobramycin | TOBRAMYCIN SULFATE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39417 | SUPPL | 2014-02-04 |