Application 078066
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CALCITRIOL | CALCITRIOL | INJECTABLE;INJECTION | 0.001MG/ML | No | Yes |
| 002 | CALCITRIOL | CALCITRIOL | INJECTABLE;INJECTION | 0.002MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-831 | Calcitriol | Calcitriol | Akorn, Inc. | ANDA | Current |
| 17478-831 | Calcitriol | Calcitriol | Akorn | ANDA | Current |
| 17478-831 | Calcitriol | Calcitriol | Akorn, Inc. | ANDA | Current |
| 17478-831 | Calcitriol | Calcitriol | Akorn | ANDA | Current |
| 17478-931 | Calcitriol | Calcitriol | Akorn, Inc. | ANDA | Current |
| 17478-931 | Calcitriol | Calcitriol | Akorn | ANDA | Current |
| 17478-931 | Calcitriol | Calcitriol | Akorn | ANDA | Current |
| 17478-931 | Calcitriol | Calcitriol | Akorn, Inc. | ANDA | Current |
| 17478-932 | Calcitriol | Calcitriol | Akorn, Inc. | ANDA | Current |
| 17478-932 | Calcitriol | Calcitriol | Akorn | ANDA | Current |
| 17478-932 | Calcitriol | Calcitriol | Akorn | ANDA | Current |
| 17478-932 | Calcitriol | Calcitriol | Akorn, Inc. | ANDA | Current |