FdaApplication
NDA 210737
Identifiers
- fda_app_no: NDA210737
Properties
| Property | Value |
|---|---|
| applicant_name | NORDIC GROUP BV |
| application_type | NDA |
| approval_date | 2019-11-27 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| REDITREX | METHOTREXATE | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 22.5MG/ML (22.5MG/ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 15MG/0.6ML (15MG/0.6ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 10MG/0.4ML (10MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 25MG/1ML (25MG/1ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION;SUBCUTANEOUS |
| REDITREX | METHOTREXATE | 20MG/0.8ML (20MG/0.8ML) | SOLUTION;SUBCUTANEOUS |
8 products