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FDA Drug Application 077463 by PAR PHARM

Application Number077463
Application Type Abbreviated New Drug Application
Sponsor ApplicantPAR PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA08/10/2006TA14692000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077463s000TAltr.pdf 8/14/2006
TA08/10/2006TA23321000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077463s000ltr.pdf 9/16/2009
TA08/10/2006TA23659000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf 10/21/2009
AP19/9/2009N14692000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077463s000TAltr.pdf 8/14/2006
AP19/9/2009N23321000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077463s000ltr.pdf 9/16/2009
AP19/9/2009N23659000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077463s000lbl.pdf 10/21/2009




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