Treats gastrointestinal stromal tumor (GIST) after disease progression on or intolerance. ANDA 213914, held by Sun Pharm. Sunitinib Malate.
As of Nov 15, 2026, ANDA 213914 (Sunitinib Malate), held by Sun Pharm, was first approved by FDA on Aug 16, 2021, with 1 approved supplement and 0 published complete response letters.
Sunitinib malate capsules are 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 |
|---|---|---|---|
| Aug 16, 2021 | Original application | Approved |
| 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 |
| Aug 21, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 16, 2021 | Original application | Approved |
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
