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FDA Drug Application 021307 by BAYER HEALTHCARE LLC

Application Number021307
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
AP012/7/2001N2982000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin_Approv.pdf 12/7/2001
AP012/7/2001N2983000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21307lbl.pdf 12/7/2001
AP012/7/2001N2984000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin.cfm 3/26/2002
AP04/3/2006SLR13885004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021307s004ltr.pdf 4/7/2006
AP03/31/2011SLR28445012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021307s012ltr.pdf 4/4/2011
AP05/2/2012SLR32614013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021307s013ltr.pdf 5/4/2012
AP012/17/2014SE841293014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021307Orig1s014ltr.pdf 12/18/2014
AP012/18/2015SLR44845015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021307Orig1s015ltr.pdf 12/22/2015
AP012/18/2015SLR44856015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021307Orig1s015lbl.pdf 12/22/2015




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