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GADOVERSETAMIDE

 
 

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FDA Approval Activities for this Drug…

OptiMark (gadoversetamide) Injection, Tyco/Mallinckrodt Health Care NDA 20-937/S3 NDA 20-975/S3 NDA 20-976/S3 1/31/03 2/12/03 2/13/03 OptiMark (gadoversetamide) Injection Mallinckrodt, NDA 20-937 | NDA 20-975 | NDA 20-976 | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Control Supplement | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Control Supplement | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Control Supplement | OptiMARK (gadoversetamide) Injection, Tyco Healthcare, Efficacy Supp. w/Clin. Data | OptiMARK (gadoversetamide) Injection, Mallinckrodt Inc., Labeling Revision | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Inc., Labeling Revision | Optimark (gadoversetamide) Injection, Covidien, Inc., Labeling Revision | Optimark (gadoversetamide) Injection, Covidien, Inc., Labeling Revision | Optimark in Plastic Container (gadoversetamide) Injection, Covidien, Inc., Labeling Revision

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