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FDA Drug Application 050679 by HOSPIRA INC

Application Number050679
Application Type New Drug Application
Sponsor ApplicantHOSPIRA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/18/1996N18664000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198675.htm 12/17/2007
AP03/13/1996SCS       
AP05/16/1997SE14305002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050679s002.cfm 5/16/1997
AP012/23/1996SCS       
AP010/20/1997SCM       
AP02/8/1999SLR       
AP01/27/1999SLR3530007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine.cfm 7/18/2001
AP01/27/1999SLR4804007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_Approv.pdf 1/27/1999
AP01/27/1999SLR4805007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf 1/27/1999
AP01/30/1998SE1       
AP08/21/2002SLR3528009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf 8/21/2002
AP01/30/1998SCP       
AP07/21/1998SCS       
AP011/24/1998SCM       
AP09/20/2000SLR       
AP08/21/2002SLR3527014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf 8/21/2002
AP06/26/2000SLR       
AP05/10/2000SCM       
AP04/2/2001SCP       
AP08/21/2002SLR3529018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf 8/21/2002
AP06/20/2001SCP       
AP03/15/2002SCS       
AP03/17/2003SE24493021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf 3/26/2003
AP03/17/2003SE24494021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50679se2-021ltr.pdf 3/26/2003
AP06/9/2004S9305023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50679slr023ltr.pdf 6/10/2004
AP06/9/2004S9320023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf 6/10/2004
AP09/14/2007SLR18581024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050679s024ltr_CKD.pdf 11/26/2007
AP09/14/2007SLR17901028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf 9/19/2007
AP05/1/2014SLR39198031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf 5/2/2014
AP05/1/2014SLR39222031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050679Orig1s031ltr.pdf 5/6/2014
AP09/30/2009SLR23476032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf 9/30/2009
AP09/30/2009SLR24056032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050679s032ltr.pdf 11/20/2009
AP03/15/2013SLR35473034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050679Orig1s034ltr.pdf 3/18/2013
AP03/15/2013SLR35480034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf 3/19/2013
AP09/6/2012SLR33685036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050679Orig1s036ltr.pdf 9/10/2012
AP09/6/2012SLR33714036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf 9/11/2012
AP06/12/2014SCM       
AP03/4/2016SCM       
AP03/1/2016SLR45335040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050679Orig1s040ltr.pdf 3/3/2016
AP03/1/2016SLR45346040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf 3/3/2016
AP06/22/2016SCM       




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