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FDA Drug Application 018353 by PFIZER

Application Number018353
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/28/1980N       
AP05/29/1981SCS       
AP012/20/1984SLR       
AP011/25/1981SCM       
AP011/2/1981SCM       
AP01/11/1982SCS       
AP06/30/1982SLR       
AP09/15/1982SCM       
AP012/2/1982SCE       
AP012/14/1983SLR       
AP08/21/1987SCM       
AP010/29/1987SCP       
AP02/17/1988SLR       
AP02/17/1988SE5       
AP02/17/1988SLR       
AP06/20/1986SCM       
AP04/24/1986SCP       
AP09/2/1986SLR       
AP09/9/1986SCM       
AP02/17/1988SLR       
AP04/13/1989SLR       
AP011/30/1992SLR       
AP03/5/1993SCM       
AP08/16/2013SLR36847026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018353Orig1s026ltr.pdf 8/20/2013
AP08/16/2013SLR36856026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf 8/21/2013
AP07/13/2015SLR43364027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018353Orig1s027ltr.pdf 7/14/2015
AP07/13/2015SLR43387027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf 7/16/2015




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