Application 212126
- Type
- ANDA
- Sponsor
- BRIGHTGENE
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 |
|---|---|---|---|---|---|
| 42806-658 | Entecavir | Entecavir | EPIC PHARMA, LLC | ANDA | Current |
| 42806-659 | Entecavir | Entecavir | EPIC PHARMA, LLC | ANDA | Current |
| 62227-101 | Entecavir | Entecavir | BrightGene Bio-Medical Technology Co., Ltd. | ANDA | Current |
| 62227-101 | Entecavir | Entecavir | BrightGene Bio-Medical Technology Co., Ltd. | ANDA | Current |
| 62227-102 | Entecavir | Entecavir | BrightGene Bio-Medical Technology Co., Ltd. | ANDA | Current |
| 62227-102 | Entecavir | Entecavir | BrightGene Bio-Medical Technology Co., Ltd. | ANDA | Current |