Application 208010
- Type
- NDA
- Sponsor
- OPKO IRELAND GLOBAL
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RAYALDEE | CALCIFEDIOL | CAPSULE, EXTENDED RELEASE;ORAL | 0.03MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70301-1001 | Rayaldee | calcifediol | OPKO Pharmaceuticals LLC | NDA | Current |
| 70301-1001 | Rayaldee | calcifediol | OPKO Pharmaceuticals LLC | NDA | Current |
| 70301-1001 | Rayaldee | calcifediol | OPKO Pharmaceuticals LLC | NDA | Current |
| 70301-1001 | Rayaldee | calcifediol | OPKO Pharmaceuticals LLC | NDA | Current |