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FDA Drug Application 019763 by BAXTER HLTHCARE

Application Number019763
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1988N       
AP02/22/1990SCS       
AP01/27/1992SCS       
AP011/10/1992SLR       
AP011/10/1992SLR       
AP06/15/1995SLR       
AP08/9/1995SLR       
AP01/23/1996SCS       
AP012/20/1996SCM       
AP09/6/2001SCM       
AP011/21/2001SCP       
AP03/23/2011SLR28346016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019763s016ltr.pdf 3/25/2011
AP03/23/2011SLR28385016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019763s016lbl.pdf 3/28/2011
AP03/1/2012SLR32006017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019763s017ltr.pdf 3/5/2012
AP03/1/2012SLR32049017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019763s017lbl.pdf 3/6/2012
AP08/28/2014SLR40350019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019763Orig1s019ltr.pdf 9/2/2014
AP08/28/2014SLR40388019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019763s019lbl.pdf 9/3/2014




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