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Application 212201
- Type
- ANDA
- Sponsor
- YAOPHARMA CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENTECAVIR | ENTECAVIR | TABLET;ORAL | 0.5MG | No | No |
| 002 | ENTECAVIR | ENTECAVIR | TABLET;ORAL | 1MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50771-013 | ENTECAVIR | entecavir | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-013 | ENTECAVIR | entecavir | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-014 | ENTECAVIR | entecavir | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-014 | ENTECAVIR | entecavir | Yaopharma Co., Ltd. | ANDA | Current |