Application 205550
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Related Records
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 |
|---|---|---|---|---|---|
| 59746-516 | darifenacin | darifenacin hydrobromide | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-516 | darifenacin | darifenacin hydrobromide | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-517 | darifenacin | darifenacin hydrobromide | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-517 | darifenacin | darifenacin hydrobromide | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |