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FDA Drug Application 202211 by ALLERGAN SALES LLC

Application Number202211
Application Type New Drug Application
Sponsor ApplicantALLERGAN SALES LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/25/2013N35007000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202211Orig1s000ltr.pdf 1/30/2013
AP01/25/2013N37695000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211_oxytrol_toc.cfm 11/5/2013
AP01/25/2013N37696000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf 11/5/2013
AP01/25/2013N37790000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf 11/12/2013
AP08/20/2013SCM       
AP08/16/2013SCM       
AP05/15/2014SCM       
AP03/3/2016SLR45370004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202211Orig1s004ltr.pdf 3/4/2016
AP03/3/2016SLR45379004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf 3/4/2016




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