Application 205432
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 0.25MG | No | No |
| 002 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 0.5MG | No | No |
| 003 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 0.75MG | No | No |
| 004 | EVEROLIMUS | EVEROLIMUS | TABLET;ORAL | 1MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51991-379 | Everolimus | Everolimus tablets | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-380 | Everolimus | Everolimus tablets | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-381 | Everolimus | Everolimus tablets | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 63850-0062 | Everolimus | Everolimus | Natco Pharma Limited | ANDA | Current |
| 63850-0063 | Everolimus | Everolimus | Natco Pharma Limited | ANDA | Current |
| 63850-0064 | Everolimus | Everolimus | Natco Pharma Limited | ANDA | Current |