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FDA Drug Application 020163 by BAXTER HLTHCARE

Application Number020163
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
AP012/4/1992N       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP06/1/1994SCS       
AP02/9/1995SCS       
AP011/22/1996SCP       
AP04/29/1997SCP       
AP08/22/2001SCS       
AP02/12/2002SCP       
AP08/9/2005SLR12581012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf 8/11/2005
AP08/9/2005SCP12582013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf 8/11/2005
AP04/19/2013SLR35784020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf 4/23/2013
AP04/19/2013SLR35836020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf 4/24/2013
AP04/26/2013SCM       
AP09/30/2014SCM       
AP02/9/2015SLR41812025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf 2/10/2015
AP02/9/2015SLR41817025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf 2/10/2015
AP06/5/2015SCM       
AP09/1/2015SLR43798027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf 9/4/2015
AP09/1/2015SLR43813027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf 9/4/2015
AP08/16/2016SLR46784028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf 8/17/2016
AP08/16/2016SLR46802028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf 8/18/2016




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