Application 210130
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EVEROLIMUS | EVEROLIMUS | TABLET, FOR SUSPENSION;ORAL | 2MG | No | No |
| 002 | EVEROLIMUS | EVEROLIMUS | TABLET, FOR SUSPENSION;ORAL | 3MG | No | No |
| 003 | EVEROLIMUS | EVEROLIMUS | TABLET, FOR SUSPENSION;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0005 | Everolimus | Everolimus | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0005 | Everolimus | Everolimus | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0006 | Everolimus | Everolimus | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0006 | Everolimus | Everolimus | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0007 | Everolimus | Everolimus | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0007 | Everolimus | Everolimus | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58813 | ORIG | 2019-05-21 |