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FDA Drug Application 006188 by DAVA PHARMS INC

Application Number006188
Application Type New Drug Application
Sponsor ApplicantDAVA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/28/1947N       
AP010/31/1980SCF       
AP010/31/1980SCE       
AP01/15/1986SLR       
AP012/4/1987SCE       
AP06/29/1990SLR       
AP04/1/1996SCS       
AP04/26/1996SCS       
AP03/11/1999SCP       
AP010/1/2001SLR21302018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf 11/28/2008
AP010/1/2001SLR21303019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf 11/28/2008
AP04/1/2010SLR25187020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf 4/4/2010
AP04/1/2010SLR25188020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020MedGuide.pdf 4/4/2010
AP04/1/2010SLR25211020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006188s020ltr.pdf 4/5/2010
AP07/27/2011SLR29631021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf 7/28/2011
AP07/27/2011SLR29635021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf 7/29/2011
AP07/27/2011SLR29632022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf 7/28/2011
AP07/27/2011SLR29636022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf 7/29/2011
AP012/19/2013SCM       
AP02/10/2015SLR41832024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006188Orig1s024ltr.pdf 2/12/2015
AP02/10/2015SLR41837024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006188s024lbl.pdf 2/12/2015
AP01/15/2016SLR44979025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006188Orig1s025ltr.pdf 1/20/2016
AP01/15/2016SLR45389025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006188s025lbl.pdf 3/8/2016




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