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FDA Drug Application 203510 by PARAGON BIOTECK

Application Number203510
Application Type New Drug Application
Sponsor ApplicantPARAGON BIOTECK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/21/2013N35502000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203510Orig1s000ltr.pdf 3/22/2013
AP03/21/2013N35528000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203510s000lbl.pdf 3/26/2013
AP03/21/2013N37179000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510_phenylephrine_toc.cfm 9/20/2013
AP03/21/2013N37180000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203510Orig1s000SumR.pdf 9/20/2013
AP010/8/2013SCM       




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