Application 212106
- Type
- ANDA
- Sponsor
- PHARMADAX INC
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 |
|---|---|---|---|---|---|
| 60050-057 | Entecavir | Entecavir | Pharmadax Inc. | ANDA | Current |
| 60050-077 | Entecavir | Entecavir | Pharmadax Inc. | ANDA | Current |
| 71921-194 | Entecavir | Entecavir | Florida Pharmaceutical Products, LLC | ANDA | Current |
| 71921-195 | Entecavir | Entecavir | Florida Pharmaceutical Products, LLC | ANDA | Current |