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FDA Drug Application 021412 by BIOVAIL LABS INTL

Application Number021412
Application Type New Drug Application
Sponsor ApplicantBIOVAIL LABS 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
TA05/26/2005TA11735000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021412TAltr.pdf 5/27/2005
TA19/21/2006TA11735000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021412TAltr.pdf 5/27/2005
AP24/25/2007N11735000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021412TAltr.pdf 5/27/2005
TA05/26/2005TA16362000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021412lbl.pdf 5/1/2007
TA19/21/2006TA16362000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021412lbl.pdf 5/1/2007
AP24/25/2007N16362000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021412lbl.pdf 5/1/2007
TA05/26/2005TA16384000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021412s000ltr.pdf 5/1/2007
TA19/21/2006TA16384000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021412s000ltr.pdf 5/1/2007
AP24/25/2007N16384000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021412s000ltr.pdf 5/1/2007
TA05/26/2005TA22235000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021412_tovalt_odt_toc.cfm 4/14/2009
TA19/21/2006TA22235000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021412_tovalt_odt_toc.cfm 4/14/2009
AP24/25/2007N22235000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021412_tovalt_odt_toc.cfm 4/14/2009




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