Application 091190
- Type
- ANDA
- Sponsor
- ANCHEN 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 |
|---|---|---|---|---|---|
| 10370-170 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-170 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-170 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-171 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-171 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-171 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Par Pharmaceutical, Inc. | ANDA | Current |
| 42291-206 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | AvKARE, Inc. | ANDA | Current |
| 42291-206 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | AvKARE, Inc. | ANDA | Current |
| 42291-207 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | AvKARE, Inc. | ANDA | Current |
| 42291-207 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | AvKARE, Inc. | ANDA | Current |
| 60429-850 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-851 | Darifenacin Hydrobromide | Darifenacin Hydrobromide | Golden State Medical Supply, Inc. | ANDA | Current |