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Application 065461
- Type
- ANDA
- Sponsor
- SANDOZ
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 |
|---|
| 0781-2102 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2102 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2102 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2102 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2102 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2103 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2103 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2103 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2103 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2103 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2104 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2104 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2104 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2104 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-2104 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-9302 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-9303 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 0781-9304 | Tacrolimus | Tacrolimus | Sandoz Inc | ANDA | Current |
| 50090-5596 | Tacrolimus | Tacrolimus | A-S Medication Solutions | ANDA | Current |
| 55154-5438 | Tacrolimus | Tacrolimus | Cardinal Health | ANDA | Current |
| 63629-8723 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 63629-8723 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 63629-8725 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 63629-8725 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 63629-8726 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 63629-8726 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 70518-2593 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2593 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2593 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 72572-760 | Tacrolimus | Tacrolimus | Civica, Inc. | ANDA | Current |
| 72572-760 | Tacrolimus | Tacrolimus | Civica, Inc. | ANDA | Current |
| 72572-761 | Tacrolimus | Tacrolimus | Civica, Inc. | ANDA | Current |
| 72572-761 | Tacrolimus | Tacrolimus | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42818 | ORIG | 2011-12-02 |
| 30664 | ORIG | 2009-08-14 |
| 18338 | ORIG | 2009-08-13 |