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FDA Drug Application 021005 by FOUGERA PHARMS

Application Number021005
Application Type New Drug Application
Sponsor ApplicantFOUGERA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2000N6101000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21005_Solaraze.cfm 7/8/2003
AP010/16/2000N870000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21005ltr.pdf 10/16/2000
AP010/16/2000N871000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21005lbl.pdf 10/16/2000
AP08/17/2001SLR       
AP010/2/2001SCS       
AP02/19/2002SCS       
AP05/20/2002SCS       
AP012/13/2002SCM       
AP04/29/2003SLR5674006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21005slr006_solaraze_lbl.pdf 5/29/2003
AP04/29/2003SLR5738006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21005slr006ltr.pdf 5/29/2003
AP03/18/2004SCS8006007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005scs007ltr.pdf 3/24/2004
AP07/23/2004SCP9853009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21005s009ltr.pdf 7/28/2004
AP06/1/2007SCM16717010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021005s010ltr.pdf 6/7/2007
AP012/8/2011SLR30961013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021005s013ltr.pdf 12/14/2011
AP012/8/2011SLR30993013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021005s013lbl.pdf 12/14/2011
AP03/30/2015SCM       
AP05/9/2016SLR45918016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021005Orig1s016ltr.pdf 5/11/2016
AP05/9/2016SLR45992016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021005s016lbl.pdf 5/11/2016
AP05/9/2016SLR46052016   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf 5/18/2016
AP05/16/2016SCM       




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