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FDA Drug Application 020062 by VALEANT INTL

Application Number020062
Application Type New Drug Application
Sponsor ApplicantVALEANT INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/1991N       
AP010/15/1992SE1       
AP08/4/1992SCM       
AP08/10/1992SE2       
AP09/18/1992SCM       
AP04/28/1993SLR       
AP06/29/1993SCS       
AP010/6/1993SLR       
AP011/1/1993SCS       
AP05/5/1994SCS       
AP04/3/1995SCP       
AP09/14/1994SCM       
AP09/28/1994SCP       
AP09/25/1995SCP       
AP010/24/1994SCS       
AP05/4/1995SCS       
AP011/22/1994SCS       
AP05/11/1995SCS       
AP010/31/1995SCS       
AP04/2/1996SLR       
AP04/2/1996SLR       
AP08/6/1997SCS       
AP011/21/1997SCM       
AP04/7/1998SCS       
AP03/21/2003SLR       
AP04/15/1999SCS       
AP08/24/1999SCF3503027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20062-s027_cardizem.pdf 7/13/2001
AP04/29/1999SCS       
AP011/18/1999SCM       
AP010/19/1999SCS       
AP012/3/1999SCM       
AP01/21/2000SCS       
AP06/4/2001SCS       
AP011/22/2010SLR27066040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020062s040lbl.pdf 11/22/2010
AP011/22/2010SLR27080040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020062s040ltr.pdf 11/30/2010
AP06/29/2016SLR46831042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020062s042lbl.pdf 8/22/2016




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