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FDA Drug Application 021119 by VALEANT LUXEMBOURG

Application Number021119
Application Type New Drug Application
Sponsor ApplicantVALEANT LUXEMBOURG
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
AP04/12/2000N1247000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21119ltr.pdf 4/12/2000
AP04/12/2000N1248000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf 4/12/2000
AP04/12/2000N2817000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-119_Visudyne.cfm 4/12/2000
AP08/22/2001SE12814001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21119s1ltr.pdf 8/22/2001
AP08/22/2001SE12815001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf 8/22/2001
AP08/22/2001SE12816001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-119S001_Visudyne.cfm 8/22/2001
AP02/15/2002SCM       
AP04/30/2002SLR2812003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s003ltr.pdf 4/30/2002
AP04/30/2002SLR2813003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf 4/30/2002
AP04/30/2002SLR11214003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s003_Visudyne.cfm 3/8/2005
AP05/29/2002SCM2810004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s004ltr.pdf 5/29/2002
AP05/29/2002SCM2811004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf 5/29/2002
AP05/29/2002SCM11213004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s004_Visudyne.cfm 3/8/2005
AP011/25/2002SLR2808005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119slr005ltr.pdf 12/9/2002
AP011/25/2002SLR2809005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf 11/25/2002
AP02/12/2004SLR7762006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf 3/2/2004
AP02/12/2004SCP7763010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf 3/2/2004
AP03/25/2005SLR11312012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21119s012ltr.pdf 3/30/2005
AP03/25/2005SLR11313012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf 3/30/2005
AP06/30/2008SE820110013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf 6/30/2008
AP06/30/2008SE820142013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021119se8-013ltr.pdf 7/1/2008
AP03/28/2007SLR16126021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf 3/31/2007
AP03/28/2007SLR16179021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021119s021ltr.pdf 4/9/2007
AP06/28/2012SLR33061022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf 6/29/2012
AP06/28/2012SLR33065022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021119s022ltr.pdf 6/29/2012
AP010/8/2013SCM       
AP05/6/2014SCM       
AP05/11/2016SLR46018027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021119Orig1s027ltr.pdf 5/12/2016
AP05/11/2016SLR46037027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf 5/17/2016




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