Application 211045
- Type
- ANDA
- Sponsor
- POLYGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 7.5MG BASE | No | No |
| 002 | DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 15MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52605-067 | Darifenacin | Darifenacin Hydrobromide | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-067 | Darifenacin | Darifenacin Hydrobromide | Polygen Pharmaceuticals Inc. | ANDA | Current |
| 52605-068 | Darifenacin | Darifenacin Hydrobromide | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-068 | Darifenacin | Darifenacin Hydrobromide | Polygen Pharmaceuticals Inc. | ANDA | Current |