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FDA Drug Application 050640 by BAXTER HLTHCARE

Application Number050640
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
AP010/26/1989N       
AP012/19/1991SLR       
AP04/5/1993SCS       
AP06/12/2000SLR       
AP02/2/1999SCM       
AP08/23/2002SLR3088006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50640slr006ltr.pdf 8/23/2002
AP03/17/2004SLR7999007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50640slr007ltr.pdf 3/24/2004
AP02/19/2014SCM       
AP04/17/2008SLR19693010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050640s010ltr.pdf 4/22/2008
AP04/17/2008SLR19952010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf 6/5/2008
AP010/13/2011SLR30336011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050640s011ltr.pdf 10/17/2011
AP010/13/2011SLR30376011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf 10/20/2011
AP04/19/2013SCM       
AP011/21/2012SLR34453015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050640Orig1s015ltr.pdf 11/23/2012
AP011/21/2012SLR34485015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf 11/28/2012
AP01/6/2015SLR41516017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050640s017lbl.pdf 1/7/2015
AP01/6/2015SLR41519017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050640Orig1s017ltr.pdf 1/8/2015
AP010/20/2016SCM       




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