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FDA Drug Application 022325 by BAXTER HLTHCARE

Application Number022325
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP012/24/2008N21445000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022325s000ltr.pdf 1/2/2009
AP012/24/2008N21459000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022325lbl.pdf 1/2/2009
AP012/24/2008N24808000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325_nexterone_toc.cfm 2/17/2010
AP012/24/2008N24809000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325s000_SumR.pdf 2/17/2010
AP011/16/2010SCM26987001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022325s001lbl.pdf 11/18/2010
AP011/16/2010SCM26995001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022325s001ltr.pdf 11/22/2010
AP012/12/2011SLR30928002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022325s002lbl.pdf 12/12/2011
AP012/12/2011SLR30974002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022325s002ltr.pdf 12/14/2011
AP01/4/2013SCM       
AP011/8/2013SCM       
AP04/5/2013SCM       
AP08/23/2013SCM       
AP04/29/2013SCM       
AP03/13/2015SLR42153009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022325Orig1s009ltr.pdf 3/17/2015
AP03/13/2015SLR42180009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022325s009lbl.pdf 3/17/2015
AP09/29/2014SCM       




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