Application 213218
- Type
- NDA
- Sponsor
- SARFEZ PHARMACEUTICALS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOAANZ | TORSEMIDE | TABLET; ORAL | 20MG | No | No |
| 002 | SOAANZ | TORSEMIDE | TABLET; ORAL | 60MG | No | No |
| 003 | SOAANZ | TORSEMIDE | TABLET;ORAL | 40MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73502-286 | SOAANZ | Torsemide | Sarfez Pharmaceuticals Inc | NDA | Current |
| 73502-287 | SOAANZ | Torsemide | Sarfez Pharmaceuticals Inc | NDA | Current |
| 73502-288 | SOAANZ | Torsemide | Sarfez Pharmaceuticals Inc | NDA | Current |
| 73502-586 | SOAANZ | Torsemide | Sarfez Pharmaceuticals Inc | NDA | Current |
| 73502-687 | SOAANZ | Torsemide | Sarfez Pharmaceuticals Inc | NDA | Current |
| 73502-786 | SOAANZ | Torsemide | Sarfez Pharmaceuticals Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71069 | ORIG | 2022-05-16 |
| 69910 | SUPPL | 2022-01-19 |
| 67826 | ORIG | 2021-06-15 |
| 67820 | ORIG | 2021-06-15 |