Application 206974
- Type
- ANDA
- Sponsor
- ARISE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMIVUDINE | LAMIVUDINE | TABLET;ORAL | 150MG | No | No |
| 002 | LAMIVUDINE | LAMIVUDINE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50742-623 | Lamivudine | Lamivudine | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-624 | Lamivudine | Lamivudine | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 69967-003 | Lamivudine | Lamivudine | ARISE PHARMACEUTICALS LLC | ANDA | Current |
| 69967-004 | Lamivudine | Lamivudine | ARISE PHARMACEUTICALS LLC | ANDA | Current |
| 70518-1083 | Lamivudine | Lamivudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1084 | Lamivudine | Lamivudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1084 | Lamivudine | Lamivudine | REMEDYREPACK INC. | ANDA | Current |