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FDA Drug Application 022283 by BAYER HEALTHCARE LLC

Application Number022283
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE 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
AP06/17/2013N36395000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022283Orig1s000ltr.pdf 6/28/2013
AP06/17/2013N37214000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022283Orig1s000lbl.pdf 9/24/2013
AP06/17/2013N41184000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000TOC.cfm 12/9/2014
AP06/17/2013N41189000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000SumR.pdf 12/9/2014
AP06/11/2015SLR43050001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022283Orig1s001ltr.pdf 6/12/2015
AP06/11/2015SLR43075001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022283Orig1s001bll.pdf 6/18/2015




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