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FDA Drug Application 050006 by PFIZER

Application Number050006
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
AP012/6/1967N       
AP03/29/1983SLR       
AP011/21/1983SLR       
AP08/23/1991SLR       
AP05/11/1992SLR       
AP02/5/1968SCE       
AP05/11/1992SLR       
AP04/8/1968SCP       
AP06/19/1968SCS       
AP06/13/1968SLR       
AP012/18/1968SCS       
AP012/30/1968SLR       
AP02/11/1969SLR       
AP02/11/1969SCP       
AP06/12/1969SCS       
AP07/31/1969SLR       
AP09/9/1969SCS       
AP09/8/1969SCS       
AP011/7/1969SCS       
AP011/19/1969SLR       
AP03/12/1970SCS       
AP03/12/1970SCS       
AP04/1/1970SCF       
AP010/14/1970SCF       
AP010/9/1970SCS       
AP02/8/1971SLR       
AP02/22/1971SCS       
AP03/12/1971SLR       
AP05/25/1971SLR       
AP09/16/1971SCS       
AP06/9/1972SLR       
AP06/23/1972SLR       
AP09/18/1972SCS       
AP03/16/1973SLR       
AP07/2/1973SLR       
AP010/30/1973SLR       
AP010/30/1973SLR       
AP010/30/1973SLR       
AP010/30/1973SLR       
AP010/2/1973SCS       
AP010/2/1973SCS       
AP04/16/1974SLR       
AP06/6/1974SLR       
AP06/21/1974SCS       
AP09/24/1974SCS       
AP09/24/1974SCS       
AP04/18/1975SLR       
AP09/16/1975SCF       
AP09/3/1975SCS       
AP09/3/1975SCS       
AP012/1/1975SCS       
AP01/15/1976SLR       
AP04/9/1976SCS       
AP05/20/1976SCS       
AP09/10/1976SCS       
AP09/13/1976SCS       
AP012/6/1976SCS       
AP09/14/1977SCS       
AP09/21/1977SCS       
AP09/20/1977SLR       
AP03/13/1978SLR       
AP07/12/1978SLR       
AP07/12/1978SLR       
AP010/19/1978SCS       
AP09/20/1979SCS       
AP09/19/1979SCS       
AP08/12/1980SLR       
AP09/16/1980SCS       
AP09/17/1980SCS       
AP010/20/1981SCS       
AP010/19/1981SCS       
AP08/31/1982SLR       
AP012/15/1992SE1       
AP06/18/2002SLR2497074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf 6/18/2002
AP03/12/2004SLR7955076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf 3/16/2004
AP02/6/2008SLR19085079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050006s079ltr.pdf 2/13/2008
AP02/6/2008SLR19118079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf 2/14/2008
AP05/11/2011SLR28828082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf 5/16/2011
AP04/29/2013SLR35892084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf 4/30/2013
AP04/29/2013SLR35913084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf 5/1/2013
AP09/4/2013SLR36984085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf 9/9/2013
AP09/4/2013SLR37012085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf 9/9/2013
AP09/12/2014SLR40493086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf 9/16/2014
AP09/12/2014SLR40696086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf 10/2/2014
AP03/31/2016SLR45579087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 4/5/2016
AP03/31/2016SLR45603087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf 4/7/2016




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