Back to FDA Applications sponsored by COVIS PHARMA SARL

FDA Drug Application 021151 by COVIS PHARMA SARL

Application Number021151
Application Type New Drug Application
Sponsor ApplicantCOVIS PHARMA SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/22/2000N1330000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21151ltr.pdf 2/22/2000
AP02/22/2000N1331000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf 2/22/2000
AP02/22/2000N13379000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021151_s000_BetapaceAFTOC.cfm 1/11/2006
AP011/22/2000SCS       
AP010/1/2001SLR       
AP03/14/2003SCS4499004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs004ltr.pdf 3/26/2003
AP04/2/2003SCS5385005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs005ltr.pdf 4/18/2003
AP02/3/2011SLR27781009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf 2/9/2011
AP02/3/2011SLR27795009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s009ltr.pdf 2/9/2011
AP08/17/2011SLR29821010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s010ltr.pdf 8/18/2011
AP08/17/2011SLR29859010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf 8/24/2011




Back to FDA Applications sponsored by COVIS PHARMA SARL