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SUTENT (nda021938)- (EQ 12.5MG BASE,EQ 25MG BASE,EQ 50MG BASE,EQ 37.5MG BASE)

SUNITINIB MALATE CPPI CV
EQ 12.5MG BASE,EQ 25MG BASE,EQ 50MG BASE,EQ 37.5MG BASE
Yes No
2021-Aug-15 2011-Jan-26
None None
None No
SUTENT 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.
7 0 6
Total Other Developers 15
Drugs with Suitability No
EQ 12.5MG BASE ** ** Up - -
EQ 25MG BASE ** ** Up - -
EQ 50MG BASE ** ** - - -
EQ 37.5MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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