FdaApplication
NDA 017029
Identifiers
- fda_app_no: NDA017029
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS KABI USA LLC |
| application_type | NDA |
| approval_date | 1985-12-05 |
Products (16)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 40 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 50 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 50 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 100 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM IN PLASTIC CONTAINER | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION |
| HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION |
16 products