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FDA Drug Application 020808 by GE HEALTHCARE

Application Number020808
Application Type New Drug Application
Sponsor ApplicantGE HEALTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/29/1997N       
AP01/28/1999SLR9637001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20808-S1_Visipaque.pdf 6/30/2004
AP09/4/2003SCP6658002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808scp002ltr.pdf 9/25/2003
AP012/18/2003SLR7354004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808slr004ltr.pdf 12/23/2003
AP012/18/2003SLR7433004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf 12/29/2003
AP01/18/2013SCM       
AP07/6/2015SLR43288024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf 7/9/2015
AP07/6/2015SLR43309024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf 7/10/2015




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