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FDA Drug Application 078088 by PAR PHARM

Application Number078088
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
TA07/16/2007TA18000000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078088TAltr.pdf 9/25/2007
TA07/16/2007TA21560000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078088ltr.pdf 1/12/2009
AP11/9/2009N18000000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078088TAltr.pdf 9/25/2007
AP11/9/2009N21560000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078088ltr.pdf 1/12/2009




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