Treats gastrointestinal stromal tumor (GIST) after disease progression on or intolerance. ANDA 215843, held by Dr Reddys. Sunitinib Malate.
As of Nov 15, 2026, ANDA 215843 (Sunitinib Malate), held by Dr Reddys, was first approved by FDA on Apr 11, 2022, with 0 approved supplements and 0 published complete response letters.
Sunitinib malate is a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. treatment of adult patients with advanced renal cell carcinoma (RCC). adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2022 | 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
