Application 215843
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43598-045 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-045 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-046 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-046 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-047 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-047 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-048 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |
| 43598-048 | SUNITINIB MALATE | SUNITINIB MALATE | Dr.Reddys Laboratories Inc | ANDA | Current |