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FDA Drug Application 050007 by PFIZER

Application Number050007
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/5/1967N       
AP08/23/1991SLR       
AP07/24/1991SCG       
AP05/11/1992SLR       
AP05/11/1992SLR       
AP012/15/1992SE1       
AP03/2/2000SCP       
AP06/18/2002SLR2498014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf 6/18/2002
AP05/15/2002SCM       
AP03/12/2004SLR7956016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf 3/16/2004
AP02/6/2008SLR19086020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050007s020ltr.pdf 2/13/2008
AP02/6/2008SLR19119020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf 2/14/2008
AP05/11/2011SLR28827023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf 5/16/2011
AP04/29/2013SLR35916025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf 5/1/2013
AP04/29/2013SLR35919025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf 5/1/2013
AP09/4/2013SLR36985026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf 9/9/2013
AP09/4/2013SLR37011026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf 9/9/2013
AP09/12/2014SLR40494027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf 9/16/2014
AP09/12/2014SLR40695027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf 10/2/2014
AP010/28/2014SCM       
AP05/5/2015SCM42746029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050007s029lbl.pdf 5/7/2015
AP03/31/2016SLR45580030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 4/5/2016
AP03/31/2016SLR45604030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf 4/7/2016




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