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Application 207934
- 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 | 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 |
|---|
| 49884-119 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-119 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-119 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-119 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-125 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-125 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-125 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-125 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-127 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-127 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-127 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-127 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-128 | Everolimus | Everolimus | Par Pharmaceutical, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48781 | ORIG | 2020-03-18 |