FdaApplication
NDA 021345
Identifiers
- fda_app_no: NDA021345
Properties
| Property | Value |
|---|---|
| applicant_name | MYLAN IRELAND LTD |
| application_type | NDA |
| approval_date | 2001-12-07 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ARIXTRA | FONDAPARINUX SODIUM | 7.5MG/0.6ML (7.5MG/0.6ML) | SOLUTION;SUBCUTANEOUS |
| ARIXTRA | FONDAPARINUX SODIUM | 5MG/0.4ML (5MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| ARIXTRA | FONDAPARINUX SODIUM | 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION;SUBCUTANEOUS |
| ARIXTRA | FONDAPARINUX SODIUM | 10MG/0.8ML (10MG/0.8ML) | SOLUTION;SUBCUTANEOUS |
4 products