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FDA Drug Application 203565 by LUITPOLD PHARMS INC

Application Number203565
Application Type New Drug Application
Sponsor ApplicantLUITPOLD PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/25/2013N36627000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203565s000ltr.pdf 7/29/2013
AP07/25/2013N36654000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203565s000lbl.pdf 7/30/2013
AP07/25/2013N36943000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000TOC.cfm 9/4/2013
AP07/25/2013N36944000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000SumR.pdf 9/4/2013
AP011/16/2014SCM       
AP012/3/2015SCM       
AP011/16/2015SCM       




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