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FDA Drug Application 022563 by STIEFEL LABS INC

Application Number022563
Application Type New Drug Application
Sponsor ApplicantSTIEFEL LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/6/2010N26621000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf 10/12/2010
AP010/6/2010N26649000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022563s000ltr.pdf 10/13/2010
AP010/6/2010N28671000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563_sorilux_toc.cfm 5/3/2011
AP010/6/2010N28672000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563Orig1s000SumR.pdf 5/3/2011
AP04/21/2011SLR28603001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf 4/22/2011
AP04/21/2011SLR28606001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022563s001ltr.pdf 4/25/2011
AP09/27/2012SE133873002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf 9/28/2012
AP09/27/2012SE133925002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022563Orig1s002ltr.pdf 10/2/2012
AP07/10/2015SCM       




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