Application 065179
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55154-9382 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Cardinal Health | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA | Current |