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FDA Drug Application 077415 by IMPAX LABS

Application Number077415
Application Type Abbreviated New Drug Application
Sponsor ApplicantIMPAX LABS
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
TA012/15/2006N15884000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf 2/23/2007
AP112/15/2006N15884000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf 2/23/2007
TA012/15/2006N29727000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf 8/9/2011
AP112/15/2006N29727000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf 8/9/2011
AP011/26/2008SCS       
AP011/26/2008SL       
AP08/30/2011SLR36065017   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf 5/14/2013
AP03/29/2012SLR36064018   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf 5/14/2013




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