ANDA 218024, held by Natco Pharma. Sunitinib Malate.
As of Nov 15, 2026, ANDA 218024 (Sunitinib Malate), held by Natco Pharma, was first approved by FDA on Oct 24, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 2023 | Original application | Approved | None posted |
| Sunitinib MalateEQ 12.5MG BASE · capsule;oral | Sunitinib Malate | Rx |
| Sunitinib MalateEQ 25MG BASE · capsule;oral | Sunitinib Malate | Rx |
| Sunitinib MalateEQ 37.5MG BASE · capsule;oral | Sunitinib Malate | Rx |
| Sunitinib MalateEQ 50MG BASE · capsule;oral | Sunitinib Malate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
