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FDA Drug Application 204655 by ASTRAZENECA LP

Application Number204655
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA LP
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
AP03/28/2014N38929000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s000Lbl.pdf 3/31/2014
AP03/28/2014N38952000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s000ltr.pdf 4/2/2014
AP03/28/2014N41186000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000TOC.cfm 12/9/2014
AP03/28/2014N41187000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204655Orig1s000SumR.pdf 12/9/2014
AP010/3/2014SLR40719001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204655Orig1s001ltr.pdf 10/6/2014
AP010/3/2014SLR40723001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204655Orig1s001lbl.pdf 10/6/2014
AP06/2/2015SLR42969002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204655Orig1s002lbl.pdf 6/3/2015
AP06/23/2015SCM       
AP06/17/2016SCM       




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