Application 212479
- Type
- NDA
- Sponsor
- THERAKIND LIMITED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | JYLAMVO | METHOTREXATE | SOLUTION;ORAL | 2MG/ML | No | No |
| 002 | JYLAMVO | METHOTREXATE | SOLUTION;ORAL | 2MG/ML | No | No |
| 003 | JYLAMVO | METHOTREXATE | SUSPENSION;ORAL | 2MG/ML | No | No |
| 004 | JYLAMVO | METHOTREXATE | SOLUTION;ORAL | 2MG/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79978 | SUPPL | 2024-10-25 |
| 79977 | SUPPL | 2024-10-25 |
| 79973 | SUPPL | 2024-10-24 |
| 79972 | SUPPL | 2024-10-24 |
| 75097 | ORIG | 2023-08-17 |
| 75096 | ORIG | 2023-08-17 |
| 75095 | ORIG | 2023-08-17 |
| 75094 | ORIG | 2023-08-17 |
| 72769 | ORIG | 2022-12-02 |
| 72768 | ORIG | 2022-12-02 |
| 72767 | ORIG | 2022-12-02 |
| 72766 | ORIG | 2022-12-02 |
| 72755 | ORIG | 2022-11-30 |
| 72754 | ORIG | 2022-11-30 |
| 72753 | ORIG | 2022-11-30 |
| 72752 | ORIG | 2022-11-30 |