Application 205007
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 4MG | No | No |
| 002 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 8MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-766 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-767 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | Aurobindo Pharma Limited | ANDA | Current |