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FDA Drug Application 022152 by BIONPHARMA INC

Application Number022152
Application Type New Drug Application
Sponsor ApplicantBIONPHARMA INC
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
AP07/29/2008N45410000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022152s000ltr.pdf 7/31/2008
AP07/29/2008N45411000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022152lbl.pdf 8/7/2008
AP07/29/2008N45412000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022152_stavzor_toc.cfm 8/25/2009
AP07/29/2008N45413000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022152s000_SumR.pdf 8/25/2009
AP02/4/2009N21795001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s001ltr.pdf 2/6/2009
AP04/23/2009SLR22409002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022152s002ltr.pdf 5/4/2009
AP04/23/2009SLR22541002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022152s002lbl.pdf 5/12/2009
AP02/26/2013SLR35273003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004ltr.pdf 2/28/2013
AP02/26/2013SLR35307003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf 3/1/2013
AP02/26/2013SLR35308004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s003s004lbl.pdf 3/1/2013
AP02/26/2013SLR35274004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s003,s004ltr.pdf 2/28/2013
AP06/14/2013SLR36303005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022152s005lbl.pdf 6/18/2013
AP06/14/2013SLR36331005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022152Orig1s005ltr.pdf 6/18/2013
AP03/7/2014SLR38730006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s006ltr.pdf 3/10/2014
AP03/7/2014SLR38734006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s006lbl.pdf 3/10/2014
AP08/28/2014SLR40357007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022152Orig1s007ltr.pdf 9/3/2014
AP08/28/2014SLR40383007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022152s007lbl.pdf 9/3/2014




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