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Application 205775
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-158 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-158 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-159 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-159 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-160 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-160 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-283 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-283 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69684 | ORIG | 2021-12-20 |