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FDA Drug Application 019668 by PFIZER

Application Number019668
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
AP011/2/1990N       
AP05/14/1991SCM       
AP07/6/1991SCM       
AP011/2/1992SCM       
AP04/29/1993SLR       
AP010/5/1993SCP       
AP07/18/1994SLR       
AP02/6/1995SLR       
AP09/13/1996SLR       
AP07/29/1997SLR       
AP07/21/1998SCM       
AP07/21/1998SCS       
AP06/13/2003SLR5954012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19668slr012ltr.pdf 6/22/2003
AP04/7/2000SCP       
AP010/10/2000SLR       
AP01/23/2002SLR2301015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19668s15ltr.pdf 1/23/2002
AP09/13/2002SCM       
AP02/28/2006SLR13723017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019668s017ltr.pdf 3/3/2006
AP07/10/2009SLR22978021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf 7/17/2009
AP07/10/2009SLR23042021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf 7/23/2009
AP01/14/2010SLR25018022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019668s022ltr.pdf 3/10/2010
AP01/14/2010SLR43704022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf 8/24/2015
AP011/6/2013SLR37730026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019668Orig1s026ltr.pdf 11/7/2013
AP011/6/2013SLR37739026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf 11/8/2013
AP07/28/2014SCM       
AP06/9/2016SLR46285028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019668Orig1s028ltr.pdf 6/10/2016
AP06/9/2016SLR46307028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf 6/13/2016




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