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FDA Drug Application 018016 by BAXTER HLTHCARE

Application Number018016
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/2/1979N       
AP02/25/1980SCS       
AP06/14/1979SCS       
AP06/28/1980SCS       
AP08/2/1979SCS       
AP08/7/1980SCS       
AP05/30/1980SCS       
AP06/18/1980SCS       
AP04/16/1981SCS       
AP07/31/1980SCS       
AP01/21/1981SCS       
AP06/29/1981SCS       
AP012/21/1981SCS       
AP08/26/1981SLR       
AP04/16/1982SCS       
AP06/3/1982SCS       
AP011/20/1981SCS       
AP07/11/1983SPD       
AP06/22/1982SCS       
AP01/24/1985SCS       
AP03/16/1984SCS       
AP08/28/1985SCS       
AP08/28/1985SCS       
AP02/28/1984SCS       
AP09/22/1984SCS       
AP06/13/1985SCS       
AP04/18/1985SLR       
AP04/15/1985SCS       
AP02/27/1986SCP       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP05/24/1990SCS       
AP03/26/1991SCS       
AP04/29/1991SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP04/29/1997SCP       
AP04/3/2002SLR3482049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf 4/3/2002
AP011/24/1999SCM       
AP08/14/2001SCM       
AP07/17/2003SCP6175053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18016scp053ltr.pdf 7/28/2003
AP16/5/2014SCM6175053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18016scp053ltr.pdf 7/28/2003
AP05/23/2005SLR11703056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018016s056ltr.pdf 5/25/2005
AP05/23/2005SLR11713056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018016s056lbl.pdf 5/25/2005
AP08/26/2005SCP12703057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf 8/31/2005
AP08/26/2005SCP12704057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf 8/31/2005
AP09/11/2013SLR37086061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf 9/13/2013
AP09/11/2013SLR37126061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf 9/17/2013
AP012/22/2014SLR41455062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf 12/30/2014
AP012/22/2014SLR41559062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf 1/8/2015




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