Application 207486
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 2.5MG | No | No |
| 002 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 5MG | No | No |
| 003 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 7.5MG | No | No |
| 004 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0054-0480 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0480 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0480 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0480 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0480 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0480 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0481 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0481 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0481 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0481 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0481 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0481 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0482 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0482 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0482 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0497 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0497 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0497 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0497 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0497 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0497 | Everolimus | Everolimus | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 59593 | ORIG | 2019-08-06 |