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FDA Drug Application 065055 by PAR PHARM

Application Number065055
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
AP012/1/2000N1461000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65055ltr.pdf 12/1/2000
AP012/19/2002SL       
AP04/18/2005S       
AP04/18/2005S       
AP07/15/2005S       
AP07/15/2005S       
AP012/14/2012SLR38454012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf 2/6/2014
AP07/10/2014SLR39966013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065055Orig1s013ltr.pdf 7/24/2014
AP07/10/2014SLR40069013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf 7/30/2014




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