Application 210538
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70710-1204 | dimethyl fumarate | dimethyl fumarate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1204 | dimethyl fumarate | dimethyl fumarate | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1205 | dimethyl fumarate | dimethyl fumarate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1205 | dimethyl fumarate | dimethyl fumarate | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1416 | dimethyl fumarate | dimethyl fumarate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1416 | dimethyl fumarate | dimethyl fumarate | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1530 | dimethyl fumarate | dimethyl fumarate | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1530 | dimethyl fumarate | dimethyl fumarate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1531 | dimethyl fumarate | dimethyl fumarate | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1531 | dimethyl fumarate | dimethyl fumarate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1532 | dimethyl fumarate | dimethyl fumarate | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1532 | dimethyl fumarate | dimethyl fumarate | Cadila Healthcare Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61121 | ORIG | 2020-02-21 |