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FDA Drug Application 020451 by CONCORDIA LABS INC

Application Number020451
Application Type New Drug Application
Sponsor ApplicantCONCORDIA LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/1995N       
AP09/10/1996SCM       
AP01/9/1998SE1357002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451sap.pdf 1/9/1998
AP012/22/1998SE1838003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451s3ltr.pdf 12/22/1998
AP03/17/1999SCS       
AP07/6/2000SLR       
AP06/15/2001SCM       
AP05/8/2001SCM       
AP09/25/2001SCM       
AP08/1/2003S6493012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf 8/14/2003
AP08/1/2003S6533012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20451s012ltr.pdf 8/15/2003
AP08/1/2003S14525012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020415s012_021525_PhotofrinTOC.cfm 7/25/2006
AP07/19/2002SCM       
AP010/29/2005SLR12922016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020451s016ltr.pdf 10/20/2005
AP09/8/2008SE820759019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020451s019lbl.pdf 9/9/2008
AP09/8/2008SE820766019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020451s019ltr.pdf 9/9/2008
AP04/4/2011SLR28459020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf 4/4/2011
AP04/4/2011SLR28469020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s020ltr.pdf 4/6/2011
AP06/24/2011SLR29306023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s023lbl.pdf 6/28/2011
AP06/24/2011SLR29388023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s023ltr.pdf 7/5/2011




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