Application 211978
- Type
- ANDA
- Sponsor
- SUNSHINE LAKE
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7891 | ENTECAVIR | ENTECAVIR | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7892 | ENTECAVIR | ENTECAVIR | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |