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FDA Drug Application 021392 by VALEANT INTL

Application Number021392
Application Type New Drug Application
Sponsor ApplicantVALEANT INTL
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
AP02/6/2003N3083000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021392lbl.pdf 2/6/2003
AP02/6/2003N11893000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-392_CardizemTOC.cfm 6/27/2005
AP04/2/2004SE18226002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21392se1-002_cardizem_lbl.pdf 4/5/2004
AP04/2/2004SE18299002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21392se1-002ltr.pdf 4/7/2004
AP04/2/2004SE117115002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021392_S002_CARDIZEM_LA_EXENTED_AP.pdf 7/6/2007
AP04/27/2007SLR16340010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021392s010lbl.pdf 5/1/2007
AP04/27/2007SLR16377010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021392s010ltr.pdf 5/1/2007
AP011/22/2010SLR27067014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021392s014lbl.pdf 11/22/2010
AP011/22/2010SLR27071014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021392s014ltr.pdf 11/30/2010
AP03/23/2015SLR42265019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021392Orig1s019ltr.pdf 3/25/2015
AP03/23/2015SLR42529019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021392s019lbl.pdf 4/14/2015




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