Back to FDA Applications sponsored by BAYER HLTHCARE

FDA Drug Application 021470 by BAYER HLTHCARE

Application Number021470
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/2002N2981000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021470lbl.pdf 12/24/2002
AP012/24/2002N8032000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea.cfm 3/24/2004
AP012/24/2002N9002000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea_Approv.pdf 6/4/2004
AP05/5/2005SE111625003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021470s003ltr.pdf 5/17/2005
AP05/5/2005SE111653003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021470s003lbl.pdf 5/17/2005
AP010/25/2010SLR26778005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021470s005lbl.pdf 10/25/2010
AP010/25/2010SLR26873005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021470s005ltr.pdf 11/3/2010
AP012/18/2012SLR34728007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021470Orig1s007ltr.pdf 12/21/2012
AP012/18/2012SLR34830007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021470s007lbl.pdf 1/7/2013
AP010/23/2014SCM       
AP02/3/2015SCM       
AP04/3/2015SLR42429010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021470Orig1s010ltr.pdf 4/6/2015
AP04/3/2015SLR42455010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s010lbl.pdf 4/7/2015
AP012/28/2015SLR44954012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s012lbl.pdf 1/11/2016
AP012/28/2015SLR44955012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021470s012ltr.pdf 1/11/2016
AP08/5/2016SLR46737013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021470Orig1s013ltr.pdf 8/9/2016
AP08/5/2016SLR46749013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021470s013lbl.pdf 8/9/2016




Back to FDA Applications sponsored by BAYER HLTHCARE