Application 205604
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-815 | Amikacin Sulfate | Amikacin Sulfate | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-815 | Amikacin Sulfate | Amikacin Sulfate | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10473 | ORIG | 2015-12-11 |