Application 090509
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 0904-6623 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-6623 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-6623 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-6624 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-6624 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-6624 | Tacrolimus | Tacrolimus | Major Pharmaceuticals | ANDA | Current |
| 55111-525 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-525 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-525 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-525 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-526 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-526 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-526 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-526 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-527 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-527 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-527 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-527 | Tacrolimus | Tacrolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 68084-449 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-449 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-449 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-449 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-450 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-450 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-450 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-450 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-451 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-451 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-451 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |
| 68084-451 | Tacrolimus | Tacrolimus | American Health Packaging | ANDA | Current |