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FDA Drug Application 019649 by CARACO

Application Number019649
Application Type New Drug Application
Sponsor ApplicantCARACO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/17/1993N       
AP02/16/1995SCS       
AP010/14/1997SCM       
AP011/8/1999SCS       
AP04/6/2001SLR5001006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf 4/11/2001
AP04/6/2001SLR9030006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf 6/4/2004
AP03/14/2007SLR16035010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf 3/15/2007
AP03/14/2007SLR16068010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019649s010;019650s007ltr.pdf 3/23/2007
AP01/8/2008SLR18801012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s012,019650s009ltr.pdf 1/9/2008
AP012/18/2008SCS       
AP011/21/2008SLR21264014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s014ltr.pdf 11/25/2008
AP011/21/2008SLR21672014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019649s014lbl.pdf 1/21/2009
AP04/5/2010SLR25229015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019649s015lbl.pdf 4/7/2010
AP04/5/2010SLR25231015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019649s015ltr.pdf 4/8/2010
AP010/19/2015SCM       




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