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FDA Drug Application 019022 by BAXTER HLTHCARE

Application Number019022
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
AP011/1/1983N       
AP012/6/1984SCS       
AP09/22/1984SCS       
AP06/13/1985SCS       
AP01/26/1985SLR       
AP04/26/1985SCS       
AP05/28/1987SCS       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP05/24/1990SCS       
AP03/26/1991SCS       
AP04/29/1991SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP04/29/1997SCP       
AP04/3/2002SLR3481017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf 4/3/2002
AP011/24/1999SCM       
AP08/14/2001SCM       
AP06/9/2005SLR11799021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019022s021ltr.pdf 6/14/2005
AP06/9/2005SLR11813021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf 6/14/2005
AP08/26/2005SCP12697022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf 8/31/2005
AP08/26/2005SCP12698022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf 8/31/2005
AP012/22/2014SLR41456026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf 12/30/2014
AP012/22/2014SLR41557026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf 1/8/2015
AP06/6/2014SCM       




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