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FDA Drug Application 050347 by PFIZER

Application Number050347
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
AP06/30/1971N       
AP03/22/1990SCG       
AP08/23/1991SCG       
AP08/26/1991SCG       
AP07/6/1971SLR       
AP08/19/1971SLR       
AP09/10/1971SLR       
AP010/4/1971SLR       
AP02/25/1972SLR       
AP04/10/1972SLR       
AP08/21/1972SLR       
AP010/24/1972SLR       
AP012/5/1972SLR       
AP03/9/1973SLR       
AP06/18/1973SLR       
AP05/23/1974SLR       
AP012/24/1974SLR       
AP07/8/1975SLR       
AP06/3/1975SLR       
AP09/12/1975SLR       
AP08/3/1976SLR       
AP011/4/1976SCS       
AP07/26/1977SCS       
AP07/13/1978SCS       
AP04/10/1979SLR       
AP04/10/1979SCP       
AP03/9/1979SLR       
AP09/10/1979SCS       
AP05/8/1980SLR       
AP010/30/1981SCS       
AP09/27/1995SLR       
AP08/1/1996SCM       
AP08/1/1996SCS       
AP07/17/2001SCM       
AP09/21/2001SCE       
AP05/15/2002SCS       
AP08/19/2004SLR10030052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50347s052ltr.pdf 8/25/2004
AP011/15/2011SLR30617058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050347s058lbl.pdf 11/16/2011
AP011/15/2011SLR30665058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050347s058ltr.pdf 11/21/2011
AP08/15/2012SLR33490060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050347s060lbl.pdf 8/16/2012
AP08/15/2012SLR33496060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050347Orig1s060ltr.pdf 8/17/2012




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