Application 207495
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMATINIB MESYLATE | IMATINIB MESYLATE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 002 | IMATINIB MESYLATE | IMATINIB MESYLATE | TABLET;ORAL | EQ 400MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-794 | Imatinib Mesylate | Imatinib | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-794 | Imatinib Mesylate | Imatinib | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-794 | Imatinib Mesylate | Imatinib | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-795 | Imatinib Mesylate | Imatinib | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-795 | Imatinib Mesylate | Imatinib | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-795 | Imatinib Mesylate | Imatinib | Amneal Pharmaceuticals LLC | ANDA | Current |