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FDA Drug Application 021885 by BERLEX LABS

Application Number021885
Application Type New Drug Application
Sponsor ApplicantBERLEX LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/2005N13323000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021885lbl.pdf 1/5/2006
AP012/27/2005N13358000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021885rev2.pdf 1/6/2006
AP012/27/2005N16873000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021885s000TOC.cfm 7/2/2007




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