Application 210296
- Type
- NDA
- Sponsor
- BANNER LIFE SCIENCES LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MONOMETHYL FUMARATE | MONOMETHYL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 95MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69387-001 | BAFIERTAM | monomethyl fumarate | Banner Life Sciences LLC | NDA | Current |
| 69387-001 | BAFIERTAM | monomethyl fumarate | Banner Life Sciences LLC | NDA | Current |
| 69387-001 | BAFIERTAM | monomethyl fumarate | Banner Life Sciences LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79757 | SUPPL | 2024-09-27 |
| 79753 | SUPPL | 2024-09-27 |
| 77099 | SUPPL | 2023-12-21 |
| 76833 | SUPPL | 2023-12-14 |
| 76800 | SUPPL | 2023-12-14 |
| 76799 | SUPPL | 2023-12-14 |
| 73159 | SUPPL | 2023-01-13 |
| 73151 | SUPPL | 2023-01-13 |
| 65392 | ORIG | 2020-11-30 |
| 62736 | ORIG | 2020-04-29 |
| 56522 | ORIG | 2020-04-29 |