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FDA Drug Application 050533 by PFIZER

Application Number050533
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/15/1980N       
AP01/21/1980SCE       
AP04/1/1980SLR       
AP02/26/1981SCS       
AP07/25/1980SCS       
AP08/12/1980SLR       
AP010/21/1980SCS       
AP04/2/1981SCE       
AP02/5/1981SCS       
AP08/23/1991SLR       
AP07/24/1991SCE       
AP05/7/1992SLR       
AP03/11/1981SCS       
AP06/30/1981SCS       
AP012/15/1981SCS       
AP012/17/1981SCF       
AP02/25/1982SCS       
AP02/16/1982SCP       
AP04/2/1982SCP       
AP08/31/1982SLR       
AP04/1/1983SLR       
AP011/21/1983SLR       
AP01/17/1984SE1       
AP02/13/1984SE1       
AP05/22/1984SCE       
AP05/11/1992SLR       
AP012/15/1992SE1       
AP05/8/1998SCS       
AP03/6/2000SCP       
AP06/18/2002SLR2502030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf 6/18/2002
AP05/15/2002SCM       
AP03/12/2004SLR7958032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf 3/16/2004
AP02/6/2008SLR19083036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050533s036ltr.pdf 2/13/2008
AP02/6/2008SLR19121036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf 2/14/2008
AP05/11/2011SLR28825038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf 5/16/2011
AP04/29/2013SLR35895040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf 4/30/2013
AP04/29/2013SLR35917040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf 5/1/2013
AP09/4/2013SLR36987041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf 9/9/2013
AP09/4/2013SLR37009041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf 9/9/2013
AP09/12/2014SLR40496042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf 9/16/2014
AP09/12/2014SLR40693042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf 10/2/2014
AP03/31/2016SLR45583043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 4/5/2016
AP03/31/2016SLR45607043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf 4/7/2016




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