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Application 212297
- Type
- ANDA
- Sponsor
- BIOCON PHARMA
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 |
|---|
| 55154-4080 | Tacrolimus | Tacrolimus | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4080 | Tacrolimus | Tacrolimus | Cardinal Health | ANDA | Current |
| 70377-014 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-014 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-014 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-015 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-015 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-015 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-016 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-016 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70377-016 | Tacrolimus | Tacrolimus | Biocon Pharma Inc. | ANDA | Current |
| 70518-2996 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-3022 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |