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FDA Drug Application 050784 by PFIZER

Application Number050784
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
AP05/24/2002N2074000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784ltr.pdf 5/24/2002
AP05/24/2002N2075000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax_prntlbl.pdf 5/24/2002
AP05/24/2002N2076000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax.cfm 5/24/2002
AP05/24/2002N35409000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP012/17/2002SCM       
AP010/16/2002SLR2073002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784slr002ltr.pdf 10/16/2002
AP01/15/2004SE17605004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-004,slr006ltr.pdf 1/22/2004
AP01/15/2004SE17622004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf 1/22/2004
AP01/15/2004SE116738004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050784_S004_S006_ZithromaxTOC.cfm 6/11/2007
AP012/18/2003SLR7311005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf 12/22/2003
AP01/15/2004SE17606006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-004,slr006ltr.pdf 1/22/2004
AP01/15/2004SE17623006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf 1/22/2004
AP01/15/2004SE116739006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050784_S004_S006_ZithromaxTOC.cfm 6/11/2007
AP010/25/2007SLR18329007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf 11/7/2007
AP010/25/2007SLR18402007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf 11/8/2007
AP02/27/2009SLR21937012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf 3/3/2009
AP02/27/2009SLR22186012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf 4/3/2009
AP08/11/2010SLR26237017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf 8/17/2010
AP08/11/2010SLR26258017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf 8/19/2010
AP01/28/2011SLR27693018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf 2/3/2011
AP01/28/2011SLR27732018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf 2/4/2011
AP011/2/2012SLR34291019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 11/6/2012
AP011/2/2012SLR34299019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf 11/6/2012
AP06/7/2014SLR39488021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf 6/10/2014
AP06/7/2014SLR39503021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf 6/11/2014
AP06/6/2012SLR32866022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf 6/8/2012
AP06/6/2012SLR32870022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf 6/11/2012
AP02/19/2013SLR35206023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf 2/21/2013
AP02/19/2013SLR35213023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf 2/21/2013
AP05/23/2016SLR46136027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf 5/25/2016
AP05/23/2016SLR46143027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf 5/25/2016




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