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AQUAMEPHYTON (nda012223)- (1MG/0.5ML,10MG/ML)

PHYTONADIONE PAI HOLDINGS PHARM
1MG/0.5ML,10MG/ML
No No
Expired Expired
None None
None No
AquaMEPHYTON is a vitamin K replacement indicated for the treatment of 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 hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; • Hypoprothrombinemia due 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 is it definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. AquaMEPHYTON is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.
6 0 5
Total Other Developers 5
Drugs with Suitability No
1MG/0.5ML ** ** - - -
10MG/ML ** ** - - -
NDA Sales Available Total Generic Sales Available
No 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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