Application 210291
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
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 |
|---|---|---|
| 56868 | ORIG | 2018-12-20 |