Back to FDA Applications sponsored by BAYER PHARMS

FDA Drug Application 021554 by BAYER PHARMS

Application Number021554
Application Type New Drug Application
Sponsor ApplicantBAYER PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/28/2003N6599000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21554ltr.pdf 9/9/2003
AP08/28/2003N6600000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21554_ciproXR_lbl.pdf 9/9/2003
AP08/28/2003N13190000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021554s000_CirpoXRTOC.cfm 12/1/2005
AP08/28/2003N45097000Review/Approval  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021554Orig1s000Approv.pdf 2/3/2016




Back to FDA Applications sponsored by BAYER PHARMS