Application 210285
- Type
- ANDA
- Sponsor
- SAWAI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 120MG | No | No |
| 002 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 240MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58379 | ORIG | 2019-04-24 |