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FDA Drug Application 020497 by PROSTRAKAN INC

Application Number020497
Application Type New Drug Application
Sponsor ApplicantPROSTRAKAN INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/29/1997N       
AP011/20/1997SLR       
AP012/1/1998SCM       
AP07/10/2000SCS       
AP03/21/2011SLR28332006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020497s006ltr.pdf 3/24/2011
AP03/21/2011SLR28380006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020497s006lbl.pdf 3/28/2011




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