Application 021068
- Type
- NDA
- Sponsor
- VALIDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROCALTROL | CALCITRIOL | SOLUTION;ORAL | 1MCG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 30698-911 | Rocaltrol | calcitriol | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-911 | Rocaltrol | calcitriol | Validus Pharmaceuticals LLC | NDA | Current |
| 63304-241 | CALCITRIOL | CALCITRIOL | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |