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FDA Drug Application 016798 by PFIZER

Application Number016798
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
AP09/23/1969N16536000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP09/23/1969N24080000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089129.pdf 11/20/2009
AP06/13/1975SDS       
AP03/31/1975SCS       
AP04/7/1975SCS       
AP06/4/1976SCS       
AP03/11/1976SCS       
AP010/28/1976SCP       
AP03/15/1978SCM       
AP03/15/1978SLR       
AP010/12/1977SCP       
AP06/6/1978SCF       
AP07/12/1978SCP       
AP07/7/1978SCS       
AP010/17/1979SLR       
AP08/12/1980SCF       
AP02/12/1981SCP       
AP07/22/1983SCS       
AP09/26/1983SCP       
AP09/26/1983SCP       
AP05/1/1984SLR       
AP05/10/1984SCP       
AP012/11/1984SCM       
AP09/13/1984SLR       
AP010/28/1985SCP       
AP09/1/1987SCP       
AP010/27/1988SCS       
AP010/27/1988SCS       
AP04/4/1990SCF       
AP07/21/1994SCM       
AP03/27/2000SCP       
AP04/10/2000SLR       
AP09/30/2003SLR6739050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17516slr020,16798slr050ltr.pdf 10/9/2003
AP02/18/2005SLR11162053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16798s053,17516s022ltr.pdf 2/23/2005
AP08/2/2007SLR17483054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf 8/3/2007
AP08/2/2007SLR17579054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP07/14/2014SLR39864056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf 7/15/2014
AP07/14/2014SLR39870056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016798Orig1s056,017516Orig1s025ltr.pdf 7/15/2014




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