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FDA Drug Application 021322 by EMD SERONO

Application Number021322
Application Type New Drug Application
Sponsor ApplicantEMD SERONO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/8/2004N10412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21322ltr.pdf 10/15/2004
AP010/8/2004N10421000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21322lbl.pdf 10/15/2004
AP010/8/2004N13186000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021322s000_LuverisTOC.cfm 11/30/2005




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