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FDA Drug Application 202513 by ALLERGAN SALES LLC

Application Number202513
Application Type New Drug Application
Sponsor ApplicantALLERGAN SALES LLC
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
AP012/7/2011N30943000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202513s000lbl.pdf 12/13/2011
AP012/7/2011N30951000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202513s000ltr.pdf 12/14/2011
AP012/7/2011N33010000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513_anturol_toc.cfm 6/26/2012
AP012/7/2011N33011000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513Orig1s000SumR.pdf 6/26/2012
AP01/9/2013SLR34864003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202513Orig1s003ltr_replacement.pdf 1/11/2013
AP01/9/2013SLR34874003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202513s003lbl.pdf 1/11/2013
AP07/10/2015SLR43330005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202513Orig1s005ltr.pdf 7/13/2015
AP07/10/2015SLR43346005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf 7/13/2015




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