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FDA Drug Application 018147 by PFIZER

Application Number018147
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/6/1982N23994000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088596.pdf 11/19/2009
AP01/13/1983SCM       
AP02/22/1983SLR       
AP03/18/1983SLR       
AP05/3/1984SCM       
AP010/21/1983SLR       
AP09/17/1984SCP       
AP09/10/1984SCP       
AP07/17/1984SLR       
AP011/19/1984SLR       
AP012/10/1984SLR       
AP09/18/1985SLR       
AP04/23/1986SCM       
AP05/14/1998SLR       
AP07/23/1987SCM       
AP08/24/1988SLR       
AP05/14/1998SLR       
AP05/16/1989SCM       
AP05/14/1998SLR       
AP05/25/1994SCM       
AP09/14/1993SCM       
AP05/14/1998SLR       
AP03/9/2000SCP       
AP01/8/2003SLR9000028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18147slr028ltr.pdf 6/4/2004
AP01/24/2006SLR13492029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf 1/25/2006
AP01/24/2006SLR13528029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018147s029ltr.pdf 1/30/2006
AP07/5/2007SLR16963030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf 7/6/2007
AP07/5/2007SLR17262030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018147s030_ltr.pdf 7/10/2007
AP08/13/2010SLR26303032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf 8/28/2010
AP08/13/2010SLR26304032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032MedGuide.pdf 8/28/2010
AP08/13/2010SLR26362032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018147s032ltr.pdf 9/7/2010
AP02/27/2015SLR41979033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf 3/2/2015
AP02/27/2015SLR42019033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf 3/4/2015
AP02/27/2015SLR41980038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf 3/2/2015
AP02/27/2015SLR42020038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf 3/4/2015
AP02/27/2015SLR41981039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf 3/2/2015
AP02/27/2015SLR42021039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf 3/4/2015
AP02/27/2015SLR41982040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf 3/2/2015
AP02/27/2015SLR42022040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf 3/4/2015
AP06/19/2013SCM       
AP02/27/2015SLR41983042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf 3/2/2015
AP02/27/2015SLR42018042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf 3/4/2015
AP05/9/2016SLR45932044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018147Orig1s044ltr.pdf 5/11/2016
AP05/9/2016SLR45943044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf 5/11/2016




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