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FDA Drug Application 020678 by BAXTER HLTHCARE

Application Number020678
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/26/1997N24440000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020678ap.pdf 1/5/2010
AP04/15/1999SCS       
AP05/25/1999SCM       
AP04/12/2000SE81368003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20678S03LTR.PDF 4/12/2000
AP04/12/2000SE82509003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-678s003_Clinimax%20E.cfm 4/12/2000
AP02/25/2000SCP       
AP03/24/2000SCS       
AP010/19/2000SCP       
AP04/4/2001SCS       
AP02/15/2002SCP       
AP07/25/2002SCS2504010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf 7/25/2002
AP07/25/2002SLR2505011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf 7/25/2002
AP05/21/2003SCS5823013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20678scs013,20734scs012ltr.pdf 6/8/2003
AP01/23/2004SLR7642014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20678slr014,20734slr013ltr.pdf 2/2/2004
AP011/2/2009SLR24538021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020678s021ltr.pdf 1/20/2010
AP09/15/2014SCM       
AP09/27/2016SLR47210027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020678s027,020734s025lbl.pdf 9/29/2016
AP09/27/2016SLR47233027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020678Orig1s027,020734Orig1s025ltr.pdf 9/30/2016
AP08/29/2014SCM       
AP09/30/2014SCM       
AP02/9/2015SCM       
AP09/1/2015SCM       
AP09/9/2016SCM       




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