Application 210305
- Type
- ANDA
- Sponsor
- CIPLA 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-322 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-322 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-322 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-322 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-322 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-322 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-323 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-323 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-323 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-323 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-323 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-323 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-552 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-552 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-552 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-552 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-552 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
| 69097-552 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56496 | ORIG | 2018-11-16 |