Application 212441
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | No | No |
| 002 | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | INJECTABLE;INJECTION | 200 UNITS/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-519 | Heparin Sodium | Heparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-519 | Heparin Sodium | Heparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 66298-5191 | Heparin Sodium | Heparin Sodium | Fresenius Kabi Norge AS | ANDA | Current |
| 66298-5197 | Heparin Sodium | Heparin Sodium | Fresenius Kabi Norge AS | ANDA | Current |