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FDA Drug Application 021538 by EMERGENT

Application Number021538
Application Type New Drug Application
Sponsor ApplicantEMERGENT
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
AP01/23/2008N18956000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021538s000ltr.pdf 1/25/2008
AP01/23/2008N18964000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021538lbl.pdf 1/30/2008
AP01/23/2008N24838000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538_accretropin_toc.cfm 2/24/2010
AP01/23/2008N24839000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021538s000_SumR.pdf 2/24/2010




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