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FDA Drug Application 050670 by PFIZER

Application Number050670
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/1/1991N35447000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/15/2013
AP04/13/1992SCP       
AP02/11/1992SLR       
AP02/29/1996SLR       
AP011/30/1993SCM       
AP011/30/1993SCM       
AP05/11/1994SCM       
AP011/22/1996SE13716008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050670ap.pdf 11/4/1997
AP012/20/1996SE5       
AP07/12/1996SCM       
AP02/24/1999SCS       
AP011/22/1999SCM       
AP011/11/2000SLR       
AP011/13/2000SE12086015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm 11/13/2000
AP011/13/2000SE15201015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf 11/13/2000
AP011/13/2000SE15202015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf 11/13/2000
AP010/16/2002SLR2083017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf 10/16/2002
AP07/22/2002SLR2077019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf 7/22/2002
AP03/24/2004SLR8098021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf 3/28/2004
AP03/24/2004SLR8212021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf 4/5/2004
AP01/15/2004SLR7596022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf 1/22/2004
AP010/25/2007SLR18323024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf 11/7/2007
AP010/25/2007SLR18403024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf 11/8/2007




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