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FDA Drug Application 019367 by BAXTER HLTHCARE

Application Number019367
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
AP04/5/1985N       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP03/26/1991SCS       
AP04/29/1991SCS       
AP012/11/1991SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP04/29/1997SCP       
AP011/24/1999SCM       
AP01/3/2003SLR3561015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19367slr015ltr.pdf 1/3/2003
AP08/14/2001SCM       
AP06/7/2005SLR11774021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019367s021ltr.pdf 6/8/2005
AP06/7/2005SLR11781021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf 6/8/2005
AP08/26/2005SCP12691022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf 8/31/2005
AP08/26/2005SCP12692022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf 8/31/2005
AP010/19/2011SLR30390026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf 10/24/2011
AP010/19/2011SLR30505026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf 11/4/2011
AP04/26/2013SCM       
AP09/30/2014SCM       




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