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FDA Drug Application 050730 by PFIZER

Application Number050730
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/12/1996N35407000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP08/12/1997SCS       
AP011/19/1999SCM       
AP01/20/2000SCP       
AP011/11/2000SLR       
AP011/13/2000SE12088005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm 11/13/2000
AP011/13/2000SE15205005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf 11/13/2000
AP011/13/2000SE15206005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf 11/13/2000
AP010/16/2002SLR2085007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf 10/16/2002
AP012/4/2001SCM       
AP07/22/2002SLR2082010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf 7/22/2002
AP03/24/2004SLR8100011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf 3/28/2004
AP03/24/2004SLR8214011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf 4/5/2004
AP01/15/2004SLR7598012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf 1/22/2004
AP010/25/2007SLR18325014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf 11/7/2007
AP010/25/2007SLR18405014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf 11/8/2007
AP03/6/2009SLR21982021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf 3/10/2009
AP03/6/2009SLR22310021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050730s021,050693s014lbl.pdf 4/23/2009
AP08/11/2010SLR26240025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf 8/17/2010
AP08/11/2010SLR26261025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf 8/19/2010
AP01/28/2011SLR27691026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf 2/3/2011
AP01/28/2011SLR27731026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf 2/4/2011
AP011/2/2012SLR34290027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf 11/6/2012
AP011/2/2012SLR34302027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf 11/6/2012
AP06/6/2014SLR39483029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf 6/10/2014
AP06/6/2014SLR39499029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf 6/11/2014
AP06/6/2012SLR32864030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf 6/8/2012
AP06/6/2012SLR32872030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf 6/11/2012
AP02/19/2013SLR35208031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf 2/21/2013
AP02/19/2013SLR35216031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf 2/21/2013
AP05/23/2016SLR46133034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf 5/25/2016
AP05/23/2016SLR46140034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf 5/25/2016




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