Back to FDA Applications sponsored by BAXTER HLTHCARE

FDA Drug Application 019970 by BAXTER HLTHCARE

Application Number019970
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
AP012/29/1989N       
AP011/9/1990SCS       
AP011/16/1990SCS       
AP06/1/1990SCS       
AP08/2/1991SLR       
AP06/29/1994SLR       
AP09/29/1994SCS       
AP03/24/1995SLR       
AP011/3/1995SLR       
AP012/9/1998SLR       
AP04/21/1999SLR       
AP010/6/2000SLR       
AP02/1/2013SCM       
AP012/31/2013SCM       
AP010/2/2014SLR40713015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019970s015lbl.pdf 10/3/2014
AP010/2/2014SLR40718015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019970Orig1s015ltr.pdf 10/3/2014
AP06/17/2015SCM       
AP08/22/2016SLR46852018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019970Orig1s018ltr.pdf 8/23/2016
AP08/22/2016SLR46863018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019970s018lbl.pdf 8/23/2016




Back to FDA Applications sponsored by BAXTER HLTHCARE