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GADOVERSETAMIDE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

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 | Optimark, gadoversetamide, Injectable; Injection, Mallinckrodt, Manufacturing Change or Addition | Optimark, gadoversetamide, Injectable; Injection, Mallinckrodt, Manufacturing Change or Addition | Optimark, gadoversetamide, Injectable; Injection, Mallinckrodt, Labeling Revision | Optimark, gadoversetamide, Injectable; Injection, Mallinckrodt, Labeling Revision | Optimark In Plastic Container, gadoversetamide, Injectable; Injection, Mallinckrodt, Labeling Revision

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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