Application 205917
- Type
- NDA
- Sponsor
- HIKMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | No | No |
| 002 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | No | No |
| 003 | PARICALCITOL | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9596 | Paricalcitol | Paricalcitol | West-Ward Pharmaceuticals Corp | NDA | Current |
| 0143-9624 | Paricalcitol | Paricalcitol | West-Ward Pharmaceuticals Corp | NDA | Current |
| 0143-9625 | Paricalcitol | Paricalcitol | West-Ward Pharmaceuticals Corp | NDA | Current |