Application 210500
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
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 |
|---|
| 31722-657 | Dimethyl Fumarate | Dimethyl Fumarate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-658 | Dimethyl Fumarate | Dimethyl Fumarate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-680 | Dimethyl Fumarate | Dimethyl Fumarate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-5288 | Dimethyl Fumarate | Dimethyl Fumarate | A-S Medication Solutions | ANDA | Current |
| 50090-5288 | Dimethyl Fumarate | Dimethyl Fumarate | A-S Medication Solutions | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57987 | ORIG | 2019-03-13 |