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FDA Drug Application 022483 by MEDICIS

Application Number022483
Application Type New Drug Application
Sponsor ApplicantMEDICIS
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
AP03/25/2010N25139000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022483s000ltr.pdf 3/29/2010
AP03/25/2010N27110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483_zyclara_toc.cfm 12/1/2010
AP03/25/2010N27911000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000SumR.pdf 2/17/2011
AP03/25/2010N27932000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf 2/18/2011
AP03/24/2011SE128350001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf 3/25/2011
AP03/24/2011SE128388001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf 3/28/2011
AP09/29/2011SLR30173002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf 9/30/2011
AP09/29/2011SLR30203002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s002ltr.pdf 10/3/2011
AP07/15/2011SE229532003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf 7/18/2011
AP07/15/2011SE229546003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s003ltr.pdf 7/19/2011
AP02/14/2012SCM31803006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022483s006ltr.pdf 2/17/2012
AP02/14/2012SCM31818006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf 2/17/2012
AP011/24/2014SCM       




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