FdaApplication
NDA 204824
Identifiers
- fda_app_no: NDA204824
Properties
| Property | Value |
|---|---|
| applicant_name | COSETTE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2013-10-11 |
Products (14)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OTREXUP | METHOTREXATE | 25MG/0.4ML (25MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 7.5MG/0.4ML (7.5MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 10MG/0.4ML (10MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 20MG/0.4ML (20MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 12.5MG/0.4ML (12.5MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 15MG/0.4ML (15MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 22.5MG/0.4ML (22.5MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP | METHOTREXATE | 17.5MG/0.4ML (17.5MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP PFS | METHOTREXATE | 15MG/0.6ML (15MG/0.6ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP PFS | METHOTREXATE | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP PFS | METHOTREXATE | 22.5MG/0.9ML (22.5MG/0.9ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP PFS | METHOTREXATE | 25MG/ML (25MG/ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP PFS | METHOTREXATE | 10MG/0.4ML (10MG/0.4ML) | SOLUTION;SUBCUTANEOUS |
| OTREXUP PFS | METHOTREXATE | 20MG/0.8ML (20MG/0.8ML) | SOLUTION;SUBCUTANEOUS |
14 products