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FDA Drug Application 020287 by PFIZER INC

Application Number020287
Application Type New Drug Application
Sponsor ApplicantPFIZER 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
AP012/22/1994N       
AP08/14/1995SLR       
AP03/18/1996SCF20569002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020287_s002_FRAGMIN INJECTION.pdf 8/11/2008
AP03/18/1996SE2       
AP04/8/1997SCS       
AP09/24/1996SLR3737005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020287a_s005edt.pdf 2/4/1998
AP01/30/1998SCF       
AP01/23/1997SCM       
AP03/30/1999SE1417008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20287s8ltr.pdf 3/30/1999
AP03/30/1999SE1418008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S008_Fragmin.cfm 3/30/1999
AP03/30/1999SE1419008   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20287s8lbl.pdf 3/30/1999
AP01/30/1998SLR       
AP05/25/1999SE1905010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin.cfm 5/25/1999
AP05/25/1999SE14724010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_appltr.pdf 5/25/1999
AP05/25/1999SE14725010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287S10_Fragmin_prntlbl.pdf 5/25/1999
AP02/27/2003SLR4232011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr011ltr.pdf 3/10/2003
AP01/22/1999SCP       
AP08/5/1999SCP17097015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287_S015_FRAGMIN_AP.pdf 7/6/2007
AP06/30/1999SCM       
AP011/14/2000SCM17096017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020287_S017_FRAGMIN_AP.pdf 7/6/2007
AP08/3/2000SE21533018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20287S18LTR.PDF 8/3/2000
AP08/3/2000SE21534018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20287S18LBL.PDF 8/3/2000
AP09/4/2001SCM       
AP04/4/2002SCP1967021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf 4/4/2002
AP04/4/2002SCP1968022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf 4/4/2002
AP04/4/2002SCP1969023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287s21ltr.pdf 4/4/2002
AP03/13/2002SCM       
AP06/19/2001SCM       
AP04/26/2002SCS       
AP011/1/2002SLR1966027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr027LTR.pdf 11/1/2002
AP09/11/2002SCS       
AP011/19/2002SLR1965029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20287slr029ltr.pdf 11/19/2002
AP07/2/2003SLR6050031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287slr031ltr.pdf 7/6/2003
AP07/2/2003SLR20400031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020287_s031_FRAGMIN INJECTION.pdf 8/1/2008
AP012/10/2003SE17254032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20287se1-032ltr.pdf 12/16/2003
AP012/10/2003SE17255032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20287se1-032_fragmin_lbl.pdf 12/16/2003
AP012/10/2003SE120401032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020287_s032_FRAGMIN INJECTION.pdf 8/1/2008
AP04/21/2004SLR8443034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20287slr034ltr.pdf 4/29/2004
AP04/21/2004SLR20379034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020287_s034_FRAGMIN INJECTION.pdf 7/31/2008
AP05/1/2007SE116433035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020287s035ltr.pdf 5/7/2007
AP05/1/2007SE116448035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020287s035lbl.pdf 5/7/2007
AP05/1/2007SE132211035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020287Orig1s035.pdf 3/27/2012
AP012/23/2009SLR24374049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020287s049lbl.pdf 12/30/2009
AP012/23/2009SLR24410049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020287s049ltr.pdf 1/5/2010
AP010/22/2010SLR26762050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020287s050lbl.pdf 10/25/2010
AP010/22/2010SLR26776050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020287s050ltr.pdf 10/26/2010
AP09/27/2013SCM       
AP010/15/2013SLR       
AP010/22/2013SCM       
AP01/26/2015SLR41695062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s062ltr.pdf 1/27/2015
AP01/26/2015SLR41739062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s062lbl.pdf 1/30/2015
AP09/29/2015SLR44064063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020287Orig1s063ltr.pdf 10/1/2015
AP09/29/2015SLR44155063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020287s063lbl.pdf 10/7/2015
AP08/4/2016SLR46727067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020287Orig1s067ltr.pdf 8/5/2016
AP08/4/2016SLR46746067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020287s067lbl.pdf 8/9/2016




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