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FDA Drug Application 018035 by JUBILANT DRAXIMAGE

Application Number018035
Application Type New Drug Application
Sponsor ApplicantJUBILANT DRAXIMAGE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/28/1978N3771000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-035_Technescan%20MDP.pdf 8/14/2002
AP05/30/1980SLR       
AP05/29/1980SCM       
AP04/26/1979SCM       
AP010/15/1979SLR       
AP012/8/1988SCS       
AP010/31/1988SLR       
AP012/30/1994SCS       
AP08/23/1996SLR       
AP04/2/1999SLR       
AP04/2/1999SLR       
AP07/3/2002SCM3532017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18035scm017ltr.pdf 7/3/2002
AP02/27/2004SCF7789018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18035scr018ltr.pdf 3/2/2004
AP07/8/2009SCF22933024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf 7/9/2009
AP07/8/2009SCF22945024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018035s024ltr.pdf 7/13/2009
AP010/22/2010SLR26761029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf 10/25/2010
AP010/22/2010SLR26773029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018035s029ltr.pdf 10/26/2010
AP09/23/2011SLR30105032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018035s032ltr.pdf 9/28/2011
AP09/23/2011SLR30126032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf 9/29/2011




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