Application 204764
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LINEZOLID | LINEZOLID | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-713 | Linezolid | Linezolid | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-713 | Linezolid | Linezolid | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-713 | Linezolid | Linezolid | Fresenius Kabi USA, LLC | ANDA | Current |
| 66298-7131 | Linezolid | LINEZOLID | Fresenius Kabi Norge AS | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10389 | ORIG | 2016-03-17 |