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FDA Drug Application 021257 by ALCON PHARMS LTD

Application Number021257
Application Type New Drug Application
Sponsor ApplicantALCON PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/16/2001N1541000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21257lbl.pdf 3/16/2001
AP03/16/2001N4023000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan.cfm 8/20/2001
AP03/16/2001N9582000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21257_Travatan_approv.pdf 6/28/2004
AP03/25/2002SCS       
AP02/15/2002SCM       
AP08/28/2002SCS       
AP012/4/2002SCS       
AP02/13/2003SE84117006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf 2/13/2003
AP02/13/2003SE84134006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf 2/13/2003
AP012/4/2002SCM       
AP02/13/2003SLR4118008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf 3/5/2003
AP02/13/2003SLR4133008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf 2/13/2003
AP02/13/2003SLR4120009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021257s006lbl.pdf 2/13/2003
AP02/13/2003SLR4132009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257se8-006,21257slr008,009ltr.pdf 2/13/2003
AP05/15/2003SCP5675010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21257scp010travatan_lbl.pdf 5/29/2003
AP05/15/2003SCP5839010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21257scp010ltr.pdf 6/8/2003
AP02/20/2004SCP7755012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21257scp012,slr013ltr.pdf 2/27/2004
AP02/20/2004SCP7830012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf 3/3/2004
AP02/20/2004SLR7756013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21257scp012,slr013ltr.pdf 2/27/2004
AP02/20/2004SLR7831013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21257scp012,slr013_travitran_lbl.pdf 3/3/2004
AP01/23/2006SCP13510014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf 1/27/2006
AP01/23/2006SCP13547014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021257s014s015ltr.pdf 1/30/2006
AP01/23/2006SLR13511015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021257s014s015LBL.pdf 1/27/2006
AP01/23/2006SLR13548015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021257s014s015ltr.pdf 1/30/2006
AP08/31/2010SE126354018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021257s018ltr.pdf 9/2/2010
AP08/31/2010SE126396018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021257s018lbl.pdf 9/7/2010
AP09/7/2011SLR29969025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021257s025lbl.pdf 9/12/2011
AP09/7/2011SLR29976025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021257s025ltr.pdf 9/12/2011




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