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FDA Drug Application 050480 by PFIZER

Application Number050480
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/23/1974N       
AP03/29/1983SLR       
AP01/6/1975SCS       
AP08/23/1991SLR       
AP05/11/1992SLR       
AP05/11/1992SLR       
AP02/25/1975SLR       
AP04/8/1975SCS       
AP06/30/1975SCS       
AP09/30/1975SCS       
AP010/21/1975SCP       
AP011/26/1975SCP       
AP03/26/1976SCS       
AP05/26/1976SCE       
AP09/27/1976SCS       
AP09/28/1976SCP       
AP09/23/1977SCS       
AP09/30/1977SCM       
AP011/23/1977SCE       
AP03/13/1978SLR       
AP07/12/1978SLR       
AP07/24/1978SLR       
AP08/1/1978SCF       
AP09/25/1978SCS       
AP011/14/1978SCE       
AP01/10/1979SLR       
AP010/2/1979SCS       
AP08/12/1980SLR       
AP09/30/1980SCF       
AP04/21/1981SCE       
AP09/29/1981SCS       
AP09/30/1981SCS       
AP08/31/1982SLR       
AP012/15/1992SE1       
AP06/18/2002SLR2501035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf 6/18/2002
AP03/1/2002SCS       
AP03/12/2004SLR7957037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf 3/16/2004
AP02/6/2008SLR19084042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050480s042ltr.pdf 2/13/2008
AP02/6/2008SLR19120042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf 2/14/2008
AP05/11/2011SLR28826047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf 5/16/2011
AP04/29/2013SLR35894050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf 4/30/2013
AP04/29/2013SLR35918050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf 5/1/2013
AP09/4/2013SLR36986051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf 9/9/2013
AP09/4/2013SLR37010051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf 9/9/2013
AP09/12/2014SLR40495052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf 9/16/2014
AP09/12/2014SLR40694052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf 10/2/2014
AP03/31/2016SLR45582054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 4/5/2016
AP03/31/2016SLR45606054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf 4/7/2016




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