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FDA Drug Application 017087 by BAXTER HLTHCARE

Application Number017087
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/28/1972N       
AP07/17/1974S       
AP011/11/1974SCS       
AP07/16/1975SCS       
AP06/18/1975SCS       
AP03/26/1976SLR       
AP08/4/1975SCS       
AP010/7/1975SCS       
AP09/3/1976SCM       
AP011/4/1976SCS       
AP011/4/1976SCS       
AP05/3/1977SLR       
AP05/30/1978SCP       
AP010/6/1977SLR       
AP09/10/1977SCS       
AP04/16/1979SCS       
AP09/6/1979SCS       
AP012/4/1979SCS       
AP07/10/1980SLR       
AP012/4/1979SCS       
AP07/24/1980SCS       
AP02/22/1982SLR       
AP010/28/1981SCS       
AP09/24/1981SCS       
AP04/17/1985SLR       
AP06/6/1984SLR       
AP04/17/1985SPD       
AP05/16/1984SCS       
AP03/24/1985SLR       
AP04/16/1986SLR       
AP04/16/1986SLR       
AP04/16/1986SCP       
AP02/25/1987SCP       
AP03/21/1990SCM       
AP07/5/1995SLR       
AP07/1/1996SCS       
AP012/9/1998SCS       
AP09/22/2000SCM       
AP010/8/2002SLR1813045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17087slr045ltr.pdf 10/8/2002
AP09/20/2006SLR14942047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf 9/21/2006
AP09/20/2006SLR14946047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017087s047ltr.pdf 9/25/2006
AP01/21/2010SLR24595048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf 1/24/2010
AP01/21/2010SLR24655048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017087s048ltr.pdf 1/28/2010




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