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FDA Drug Application 020280 by PHARMACIA AND UPJOHN

Application Number020280
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
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
AP08/24/1995N       
AP012/20/1995SLR       
AP04/24/1996SCM       
AP04/19/1996SLR       
AP05/24/1996SCS       
AP07/15/1996SCM       
AP011/19/1996SCS       
AP010/23/1996SCS       
AP010/31/1997SE127745008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020280s008.pdf 2/4/2011
AP01/27/1998SCS       
AP01/5/1998SCS       
AP08/4/1998SCS       
AP08/18/1998SCS       
AP04/30/1999SCS       
AP07/30/1998SCS       
AP02/24/1999SCM       
AP04/27/1999SCS       
AP04/30/1999SCS       
AP01/19/2000SCS       
AP07/11/2000SCM       
AP04/11/2000SCM       
AP06/20/2000SE11488023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF 6/20/2000
AP05/12/2000SCS       
AP07/11/2000SLR       
AP05/26/2000SCS       
AP07/31/2000SCS       
AP08/18/2000SLR       
AP010/5/2000SCM       
AP07/21/2000SCS       
AP07/25/2001SE12110031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20280s31ltr.pdf 7/25/2001
AP07/25/2001SE12111031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf 7/25/2001
AP07/25/2001SE12112031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-280S031_Genotropin.cfm 7/25/2001
AP011/7/2000SCM       
AP012/8/2000SCM       
AP01/26/2001SCS       
AP07/9/2001SCM       
AP09/21/2001SCM       
AP01/29/2002SCS       
AP03/28/2003SCM5281038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scm038ltr.pdf 4/15/2003
AP08/15/2002SCM       
AP05/12/2003SCS5663040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf 5/29/2003
AP05/12/2003SCS5811040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scs040ltr.pdf 6/8/2003
AP011/5/2002SCS       
AP010/31/2003SLR6979044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280slr044ltr.pdf 11/25/2003
AP04/27/2006SE113998049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf 5/1/2006
AP04/27/2006SE114034049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020280s049LTR.pdf 5/1/2006
AP04/27/2006SE127029049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020280_s049_genotropin_medr.pdf 4/1/2006
AP07/22/2007SCS17333055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf 7/24/2007
AP07/22/2007SCS17351055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf 7/24/2007
AP18/10/2007SCS17333055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf 7/24/2007
AP18/10/2007SCS17351055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf 7/24/2007
AP03/14/2007SLR16024057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s057ltr.pdf 3/15/2007
AP03/14/2007SLR16038057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf 3/15/2007
AP06/12/2008SE120012060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s060ltr.pdf 6/13/2008
AP06/12/2008SE120029060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf 6/18/2008
AP06/12/2008SE120215060   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020280se1-060_SUMR.pdf 7/16/2008
AP01/5/2009SCS21531061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf 1/6/2009
AP01/5/2009SCS21546061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s061ltr.pdf 1/6/2009
AP05/20/2009SCM22615064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf 5/25/2009
AP05/20/2009SCM22619064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s064ltr.pdf 5/26/2009
AP012/15/2008SLR21369066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s066ltr.pdf 12/19/2008
AP012/15/2008SLR21475066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf 1/2/2009
AP02/2/2010SLR24762068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf 2/16/2010
AP02/2/2010SLR24784068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020280s068ltr.pdf 2/16/2010
AP05/17/2011SLR28858071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020280s071ltr.pdf 5/19/2011
AP05/17/2011SLR28905071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf 5/23/2011
AP02/6/2012SLR31694072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf 2/6/2012
AP02/6/2012SLR31711072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020280s072ltr.pdf 2/8/2012
AP04/19/2013SCM       
AP010/17/2013SCM       
AP09/25/2014SLR40645077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020280Orig1s077ltr.pdf 9/29/2014
AP09/25/2014SLR40654077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf 9/30/2014
AP06/22/2015SLR43109078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020280Orig1s078ltr.pdf 6/24/2015
AP06/22/2015SLR43113078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf 6/24/2015
AP09/6/2016SLR46984079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s079ltr.pdf 9/7/2016
AP09/6/2016SLR46997079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf 9/8/2016
AP02/16/2015SCM       
AP09/10/2015SCM       
AP012/28/2015SCM       
AP06/16/2016SCM       
AP08/15/2016SCM       




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