Application 210436
- Type
- ANDA
- Sponsor
- PHARMATHEN SA
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71348-100 | Dimethyl fumarate | Dimethyl fumarate | PHARMATHEN INTERNATIONAL S.A. | ANDA | Current |
| 71348-101 | Dimethyl fumarate | Dimethyl fumarate | PHARMATHEN INTERNATIONAL S.A. | ANDA | Current |
| 71348-102 | dimethyl fumarate | dimethyl fumarate | PHARMATHEN INTERNATIONAL S.A. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65437 | ORIG | 2020-12-01 |