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FDA Drug Application 020812 by PFIZER

Application Number020812
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/30/1998N11863000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020812_PediatricTOC.cfm 6/23/2005
AP06/19/1998SCP       
AP05/19/1998SCM       
AP01/12/2000SE514477003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf 7/18/2006
AP010/14/1998SCM       
AP02/10/2000SCS       
AP09/7/2000SLR36023007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020812Orig1s007.pdf 5/10/2013
AP08/2/2001SCS       
AP06/28/2002SCS       
AP09/10/2004SLR10205011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20812s011ltr.pdf 9/15/2004
AP09/10/2004SLR35750011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020812Orig1s011.pdf 4/18/2013
AP04/4/2006SLR13879012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020812s012ltr.pdf 4/7/2006
AP06/11/2008SLR20016014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020812s014ltr.pdf 6/16/2008
AP05/19/2009SLR22628015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020812s015ltr.pdf 5/27/2009
AP04/26/2011SLR28616017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020812s017ltr.pdf 4/28/2011
AP07/24/2013SCM36620019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020812Orig1s019ltr.pdf 7/26/2013
AP07/24/2013SCM36688019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf 8/5/2013
AP012/6/2013SCM       
AP03/11/2014SCM       
AP02/26/2015SCM       




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