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FDA Drug Application 020589 by PFIZER

Application Number020589
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/27/1996N       
AP011/7/1997SCF       
AP05/5/1998SCM       
AP010/14/1998SCM       
AP010/17/1999SCP       
AP08/25/2000SLR       
AP03/30/2000SCS       
AP07/14/2000SCP       
AP09/17/2001SCS       
AP08/2/2001SCF5475013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf 4/25/2003
AP08/2/2001SCS       
AP011/14/2002SLR       
AP03/18/2005SLR11278017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20589s017ltr.pdf 3/23/2005
AP03/18/2005SLR11284017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf 3/23/2005
AP012/7/2005SLR13279019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020589s019ltr.pdf 12/15/2005
AP06/11/2008SLR20017023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020589s023ltr.pdf 6/16/2008
AP05/19/2009SLR22626024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020589s024ltr.pdf 5/26/2009
AP09/2/2010SLR26377026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020589s026ltr.pdf 9/7/2010
AP012/20/2013SCM38154029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020589Orig1s029ltr.pdf 12/24/2013
AP012/20/2013SCM38254029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf 1/13/2014
AP09/4/2012SCM       
AP012/7/2012SCM       
AP06/12/2013SCM       
AP07/28/2016SCM       




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