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FDA Drug Application 050693 by PFIZER

Application Number050693
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
AP09/28/1994N35404000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP011/22/1999SCM       
AP011/11/2000SLR       
AP011/13/2000SE12087003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm 11/13/2000
AP011/13/2000SE15203003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf 11/13/2000
AP011/13/2000SE15204003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf 11/13/2000
AP010/16/2002SLR2084005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf 10/16/2002
AP07/22/2002SLR2078007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf 7/22/2002
AP03/24/2004SLR8099008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf 3/28/2004
AP03/24/2004SLR8213008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf 4/5/2004
AP01/15/2004SLR7597009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf 1/22/2004
AP010/25/2007SLR18324010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf 11/7/2007
AP010/25/2007SLR18404010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf 11/8/2007
AP03/6/2009SLR21981014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf 3/10/2009
AP03/6/2009SLR22187014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050693s014,050730s021lbl.pdf 4/3/2009
AP08/11/2010SLR26239015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf 8/17/2010
AP08/11/2010SLR26262015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf 8/19/2010
AP01/28/2011SLR27688017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf 2/3/2011
AP01/28/2011SLR27736017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf 2/4/2011
AP011/2/2012SLR34286019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 11/6/2012
AP011/2/2012SLR34305019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf 11/6/2012
AP06/6/2014SLR39484021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf 6/10/2014
AP06/6/2014SLR39498021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf 6/11/2014
AP06/6/2012SLR32861022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf 6/8/2012
AP06/6/2012SLR32875022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf 6/11/2012
AP02/19/2013SLR35207023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf 2/21/2013
AP02/19/2013SLR35217023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf 2/21/2013
AP011/5/2014SCM       
AP05/23/2016SLR46132026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf 5/25/2016
AP05/23/2016SLR46139026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf 5/25/2016




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