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FDA Drug Application 017516 by PFIZER

Application Number017516
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
AP03/11/1974N16537000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP03/11/1974N23718000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017516_OriginalApprovalPackage.pdf 11/2/2009
AP09/23/1974SCS       
AP03/31/1975SOA       
AP06/30/1976SCE       
AP06/8/1978SCS       
AP011/30/1981SCS       
AP05/1/1984SLR       
AP09/13/1984SLR       
AP03/22/1988SLR       
AP012/4/1989SCM       
AP07/21/1994SCM       
AP04/10/2000SLR       
AP09/30/2003SLR6740020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17516slr020,16798slr050ltr.pdf 10/9/2003
AP02/18/2005SLR11163022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16798s053,17516s022ltr.pdf 2/23/2005
AP08/2/2007SLR17482023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf 8/3/2007
AP08/2/2007SLR17578023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007
AP07/14/2014SLR39863025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016798s056,017516s025lbl.pdf 7/15/2014
AP07/14/2014SLR39871025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016798Orig1s056,017516Orig1s025ltr.pdf 7/15/2014




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