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SAMSCA (nda022275)- (15MG,30MG,60MG)

TOLVAPTAN OTSUKA
15MG,30MG,60MG
Yes No
2030-Apr-07 2014-May-19
None None
None No
SAMSCA is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
5 1 5
Total Other Developers 5
Drugs with Suitability No
15MG ** ** - - 5
30MG ** ** - - -
60MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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