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FDA Drug Application 050710 by PFIZER

Application Number050710
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
AP010/19/1995N35405000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP012/20/1996SE5       
AP03/14/1996SCS       
AP03/18/1996SCS       
AP011/8/1999SCP       
AP011/22/1999SCM       
AP011/11/2000SLR       
AP010/16/2002SLR2093007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710slr007,50711slr008ltr.pdf 10/16/2002
AP012/14/2001SE22102008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf 12/14/2001
AP012/14/2001SE22103008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s8lbl.pdf 12/14/2001
AP012/14/2001SE22104009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf 12/14/2001
AP012/14/2001SE22105009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s9lbl.pdf 12/14/2001
AP05/24/2002SLR2097011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710s011ltr.pdf 5/24/2002
AP05/24/2002SLR2099011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50710s11lbl.pdf 5/24/2002
AP05/24/2002SLR9049011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-710S011_50-711S009_Zithromax.cfm 6/4/2004
AP012/10/2001SCM       
AP07/22/2002SLR2079014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf 7/22/2002
AP06/20/2003SLR6067016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50710slr016ltr.pdf 7/6/2003
AP01/15/2004SLR7599017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf 1/22/2004
AP01/15/2004SLR7618017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf 1/22/2004
AP04/27/2004SLR8408019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr019ltr.pdf 4/29/2004
AP012/18/2003SLR7310020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf 12/22/2003
AP01/15/2004SLR7600021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf 1/22/2004
AP01/15/2004SLR7619021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf 1/22/2004
AP010/25/2007SLR18327023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf 11/7/2007
AP010/25/2007SLR18400023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf 11/8/2007
AP02/27/2009SLR21935028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf 3/3/2009
AP02/27/2009SLR22184028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf 4/3/2009
AP08/11/2010SLR26235032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf 8/17/2010
AP08/11/2010SLR26260032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf 8/19/2010
AP01/28/2011SLR27689033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf 2/3/2011
AP01/28/2011SLR27735033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf 2/4/2011
AP011/2/2012SLR34287034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 11/6/2012
AP011/2/2012SLR34304034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf 11/6/2012
AP06/7/2014SLR39490037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf 6/10/2014
AP06/7/2014SLR39501037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf 6/11/2014
AP06/6/2012SLR32862038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf 6/8/2012
AP06/6/2012SLR32874038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf 6/11/2012
AP02/19/2013SLR35204039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf 2/21/2013
AP02/19/2013SLR35215039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf 2/21/2013
AP05/23/2016SLR46134043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf 5/25/2016
AP05/23/2016SLR46141043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf 5/25/2016




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