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FDA Drug Application 079108 by IMPAX LABS INC

Application Number079108
Application Type Abbreviated New Drug Application
Sponsor ApplicantIMPAX LABS INC
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
TA011/21/2013TA37973000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf 12/5/2013
AP111/21/2013N37973000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf 12/5/2013
AP25/19/2014N37973000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf 12/5/2013
AP38/5/2015N37973000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf 12/5/2013
AP412/21/2015N37973000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf 12/5/2013




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