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MEPHYTON (nda010104)- (5MG)

PHYTONADIONE BAUSCH
5MG
No No
Expired Expired
None None
None No
Mephyton is a vitamin K replacement indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity: • Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; • Hypoprothrombinemia secondary to antibacterial therapy; • Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; • Other drug-induced hypoprothrombinemia where it is definitively shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
4 0 4
Total Other Developers 22
Drugs with Suitability No
5MG ** ** - - 3
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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