Back to FDA Applications sponsored by PFIZER

FDA Drug Application 050711 by PFIZER

Application Number050711
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
AP07/18/1996N12542000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050711_Original_ap_pkg.PDF 8/4/2005
AP07/18/1996N35406000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP05/16/1997SCS       
AP07/15/1999SCM       
AP010/6/1999SCM       
AP011/22/1999SCM       
AP012/6/1999SCP       
AP011/11/2000SLR       
AP02/9/2000SCM       
AP010/16/2002SLR2096008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710slr007,50711slr008ltr.pdf 10/16/2002
AP05/24/2002SLR2100009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710s011ltr.pdf 5/24/2002
AP05/24/2002SLR2101009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50710s11lbl.pdf 5/24/2002
AP05/24/2002SLR9048009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-710S011_50-711S009_Zithromax.cfm 6/4/2004
AP012/10/2001SCM       
AP07/22/2002SLR2080012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf 7/22/2002
AP05/20/2002SCP       
AP01/15/2004SLR7601015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf 1/22/2004
AP01/15/2004SLR7620015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf 1/22/2004
AP012/18/2003SLR7309016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf 12/22/2003
AP01/15/2004SLR7621017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf 1/22/2004
AP01/15/2004SLR7602017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf 1/22/2004
AP010/25/2007SLR18328019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf 11/7/2007
AP010/25/2007SLR18401019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf 11/8/2007
AP02/27/2009SLR21936024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf 3/3/2009
AP02/27/2009SLR22185024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf 4/3/2009
AP08/11/2010SLR26236030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf 8/17/2010
AP08/11/2010SLR26259030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf 8/19/2010
AP01/28/2011SLR27690031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf 2/3/2011
AP01/28/2011SLR27733031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf 2/4/2011
AP011/2/2012SLR34288032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 11/6/2012
AP011/2/2012SLR34303032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf 11/6/2012
AP06/7/2014SLR39489034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf 6/10/2014
AP06/7/2014SLR39502034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf 6/11/2014
AP06/6/2012SLR32863035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf 6/8/2012
AP06/6/2012SLR32873035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf 6/11/2012
AP02/19/2013SLR35205036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf 2/21/2013
AP02/19/2013SLR35214036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf 2/21/2013
AP05/23/2016SLR46135040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf 5/25/2016
AP05/23/2016SLR46142040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf 5/25/2016




Back to FDA Applications sponsored by PFIZER

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.