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FDA Drug Application 050551 by PFIZER

Application Number050551
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
AP011/18/1982N       
AP03/5/1990SLR       
AP09/29/1988SLR       
AP010/28/1994SLR       
AP012/7/2001SCS       
AP012/18/2002SLR5084042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pdf 4/9/2003
AP012/18/2002SLR8809042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50551slr042ltr.pdf 5/28/2004
AP03/18/2015SLR42207043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050551s043lbl.pdf 3/19/2015
AP03/18/2015SLR42212043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050551Orig1s043ltr.pdf 3/19/2015




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