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FDA Drug Application 019385 by VALEANT PHARM INTL

Application Number019385
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARM INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1988N16107000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143341.htm 3/29/2007
AP03/17/1989SCS       
AP011/2/1989SLR       
AP011/27/1989SCM       
AP010/6/1999SLR       
AP01/8/1993SCM       
AP05/15/1991SCS       
AP01/8/1993SCP       
AP010/6/1999SLR       
AP01/11/1993SCP       
AP01/11/1993SCS       
AP012/15/1994SCS       
AP012/15/1994SCS       
AP012/15/1994SCS       
AP011/29/1994SCF       
AP010/6/1999SLR       
AP010/6/1999SLR       
AP010/6/1999SLR       
AP010/6/1999SLR       
AP04/3/1998SCP       
AP04/13/1998SCM       
AP06/26/1998SCM       
AP04/13/1999SCM       
AP010/6/1999SLR       
AP010/1/1999SCM       
AP08/29/2002SLR3391028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19385slr028ltr.pdf 8/29/2002
AP012/7/2000SCS       
AP010/2/2003SLR6742030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf 10/9/2003
AP010/2/2003SLR6772030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf 10/10/2003
AP010/2/2003SLR6773031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf 10/10/2003
AP010/2/2003SLR21569031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019385_S031_PERMAX.pdf 1/12/2009
AP010/2/2003SLR6743031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf 10/9/2003
AP05/17/2002SCS       
AP010/2/2003SLR6744035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19385slr030,031,035ltr.pdf 10/9/2003
AP010/2/2003SLR21570035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019385_S035_PERMAX.pdf 1/12/2009
AP010/2/2003SLR6774035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf 10/10/2003




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