Application 209139
- Type
- NDA
- Sponsor
- CARMEL BIOSCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREXXARTAN | VALSARTAN | SOLUTION;ORAL | 20MG/5ML | Yes | No |
| 002 | PREXXARTAN | VALSARTAN | SOLUTION;ORAL | 80MG/20ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25208-100 | PREXXARTAN | PREXXARTAN | Medicure International Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 54736 | ORIG | 2018-07-02 |
| 50902 | ORIG | 2017-12-27 |
| 50759 | ORIG | 2017-12-19 |