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FDA Drug Application 020965 by DUSA

Application Number020965
Application Type New Drug Application
Sponsor ApplicantDUSA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/3/1999N2874000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20965ltr.pdf 12/7/1999
AP012/3/1999N2875000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20965lbl.pdf 12/7/1999
AP012/3/1999N2876000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-965_Levulan.cfm 12/7/1999
AP07/27/2001SCE       
AP03/26/2003SLR4658002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr002_levulan_lbl.pdf 3/28/2003
AP03/26/2003SLR4659002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr002ltr.pdf 3/28/2003
AP06/27/2003SLR6057003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965slr003ltr.pdf 7/6/2003
AP06/27/2003SLR6083003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20965slr003_levulan_lbl.pdf 7/8/2003
AP07/11/2003SCM6159004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965scm004ltr.pdf 7/28/2003
AP07/17/2009SLR23049006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020965s006lbl.pdf 7/23/2009
AP07/17/2009SLR24085006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020965s006ltr.pdf 11/20/2009
AP03/12/2010SE825045007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020965s007lbl.pdf 3/17/2010
AP03/12/2010SE825068007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020965s007ltr.pdf 3/18/2010
AP011/14/2013SCM       
AP01/7/2016SCM       




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