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FDA Drug Application 012141 by BAXTER HLTHCARE

Application Number012141
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/16/1959N       
AP010/18/1976SOA       
AP04/29/1987SE1       
AP03/17/1977SCM       
AP06/9/1976SCS       
AP06/9/1976SCS       
AP011/1/1976SLR       
AP010/18/1976SCS       
AP03/17/1977SCS       
AP05/16/1977SCM       
AP08/8/1978SCS       
AP04/25/1977SCS       
AP011/16/1977SLR       
AP011/16/1977SCM       
AP05/23/1978SCS       
AP07/19/1978SCS       
AP011/27/1978SCM       
AP08/16/1978S       
AP08/28/1978SCS       
AP04/30/1979SCM       
AP01/25/1980SCM       
AP05/24/1979SCP       
AP08/3/1979SCS       
AP02/27/1981SCS       
AP09/27/1980SLR       
AP07/28/1982SCS       
AP04/29/1987SPD       
AP03/4/1982SCP       
AP03/15/1983SLR       
AP08/10/1984SCS       
AP012/5/1985SCF       
AP08/30/1985SCM       
AP012/4/1985SLR       
AP01/15/1986SLR       
AP07/11/1986SLR       
AP07/11/1986SLR       
AP07/11/1986SLR       
AP07/11/1986SLR       
AP04/29/1987SCM       
AP012/20/1995SLR       
AP06/15/2000SLR       
AP05/28/1999SLR       
AP08/20/1999SCM       
AP01/30/2001SLR       
AP02/27/2003SLR4261087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12141slr087ltr.pdf 3/10/2003
AP03/31/2012SLR32342089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf 4/2/2012
AP03/31/2012SLR32352089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012141s089ltr.pdf 4/4/2012
AP05/7/2013SLR35988090   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf 5/9/2013
AP05/7/2013SLR36018090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012141Orig1s090,012142Orig1s112ltr.pdf 5/10/2013




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