Application 206662
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS 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 |
|---|
| 16714-098 | tacrolimus | tacrolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-099 | tacrolimus | tacrolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-100 | tacrolimus | tacrolimus | NORTHSTAR RX LLC | ANDA | Current |
| 50090-5581 | tacrolimus | tacrolimus | A-S Medication Solutions | ANDA | Current |
| 68462-685 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-685 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-685 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-686 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-686 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-686 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-687 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-687 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-687 | tacrolimus | tacrolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |