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FDA Drug Application 019281 by PHARMACIA AND UPJOHN

Application Number019281
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1986N       
AP07/24/1996SCM       
AP011/7/1994SCS       
AP012/5/1996SCS       
AP07/24/1996SCS       
AP07/24/1996SCM       
AP011/7/1994SCS       
AP07/24/1996SCS       
AP07/24/1996SCM       
AP09/9/1999SLR2659009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf 6/18/2001
AP09/9/1999SLR2660009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf 9/9/1999
AP011/15/1999SCS       
AP04/28/2000SCS       
AP07/31/2001SCM       
AP03/27/2001SLR1600013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19281S13LTR.PDF 3/27/2001
AP010/31/2001SLR       
AP011/2/2001SCM       
AP011/2/2001SCP       
AP04/16/2002SCS       
AP05/15/2002SCM       
AP012/22/2008SLR21407025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019281s025ltr.pdf 12/24/2008
AP012/22/2008SLR21457025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019281s025lbl.pdf 1/2/2009
AP01/28/2009SLR21688027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019281s027ltr.pdf 1/30/2009
AP01/25/2011SLR27639030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf 1/31/2011
AP01/25/2011SLR27670030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019281s030ltr.pdf 2/2/2011
AP05/10/2013SLR36050031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019281s031lbl.pdf 5/14/2013
AP05/10/2013SLR36058031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019281Orig1s031ltr.pdf 5/14/2013
AP012/15/2014SCM42524033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019281s033lbl.pdf 4/14/2015
AP04/17/2015SCM       
AP06/1/2015SCM       
AP010/20/2015SCM       
AP02/1/2016SCM       
AP08/29/2016SCM       
AP08/1/2016SCM       




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