Application 091195
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Related Records
Application Products
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6425 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-6425 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-041 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-042 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 16729-043 | Tacrolimus | Tacrolimus | Accord Healthcare Inc. | ANDA | Current |
| 50090-2245 | Tacrolimus | Tacrolimus | A-S Medication Solutions | ANDA | Current |
| 50090-2245 | Tacrolimus | Tacrolimus | A-S Medication Solutions | ANDA | Current |
| 55154-2675 | Tacrolimus | Tacrolimus | Cardinal Health | ANDA | Current |
| 55154-2675 | Tacrolimus | Tacrolimus | Cardinal Health | ANDA | Current |
| 63629-9325 | Tacrolimus | Tacrolimus | Bryant Ranch Prepack | ANDA | Current |
| 68788-7331 | Tacrolimus | Tacrolimus | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2124 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2124 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2124 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2124 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-2124 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |
| 70518-3216 | Tacrolimus | Tacrolimus | REMEDYREPACK INC. | ANDA | Current |