Application 213803
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 12.5MG BASE | No | No |
| 002 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 003 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 37.5MG BASE | No | No |
| 004 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-8199 | Sunitinib Malate | Sunitinib Malate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8224 | Sunitinib Malate | Sunitinib Malate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8229 | Sunitinib Malate | Sunitinib Malate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8231 | Sunitinib Malate | Sunitinib Malate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |