Application 090802
- Type
- ANDA
- Sponsor
- PANACEA BIOTEC LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TACROLIMUS | TACROLIMUS | CAPSULE;ORAL | EQ 0.5MG BASE | No | No |
| 002 | TACROLIMUS | TACROLIMUS | CAPSULE;ORAL | EQ 1MG BASE | No | No |
| 003 | TACROLIMUS | TACROLIMUS | CAPSULE;ORAL | EQ 5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43817-421 | Tacrolimus | Tacrolimus | Panacea Biotec Limited | ANDA | Current |
| 43817-421 | Tacrolimus | Tacrolimus | Panacea Biotec Ltd | ANDA | Current |
| 43817-422 | Tacrolimus | Tacrolimus | Panacea Biotec Ltd | ANDA | Current |
| 43817-422 | Tacrolimus | Tacrolimus | Panacea Biotec Limited | ANDA | Current |
| 43817-423 | Tacrolimus | Tacrolimus | Panacea Biotec Ltd | ANDA | Current |
| 43817-423 | Tacrolimus | Tacrolimus | Panacea Biotec Limited | ANDA | Current |
| 62175-380 | Tacrolimus | Tacrolimus | Kremers Urban Pharmaceuticals Inc. | ANDA | Current |
| 62175-381 | Tacrolimus | Tacrolimus | Kremers Urban Pharmaceuticals Inc. | ANDA | Current |
| 62175-382 | Tacrolimus | Tacrolimus | Kremers Urban Pharmaceuticals Inc. | ANDA | Current |
| 69452-153 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-153 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-153 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-154 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-154 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-154 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-155 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-155 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |
| 69452-155 | Tacrolimus | Tacrolimus | BionPharma Inc., | ANDA | Current |