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Application 214182
- Type
- ANDA
- Sponsor
- BIOCON PHARMA
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 |
|---|
| 70377-010 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-010 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-011 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-011 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-012 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-012 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-013 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-013 | EVEROLIMUS | everolimus | Biocon Pharma Inc. | ANDA | Current |