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FDA Drug Application 019481 by UNITED GUARDIAN

Application Number019481
Application Type New Drug Application
Sponsor ApplicantUNITED GUARDIAN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/1990N       
AP04/16/1993SCM       
AP04/13/1993SCS       
AP012/3/1993SCS       
AP010/28/1996SCS       
AP08/31/1998SCS       
AP09/30/1998SCS       
AP05/3/2007SCM16495007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019481s007ltr.pdf 5/9/2007
AP02/12/2014SCM       
AP012/16/2015SCM       
AP010/30/2015SLR44354013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019481Orig1s013ltr.pdf 11/4/2015
AP010/30/2015SLR44364013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019481s013lbl.pdf 11/4/2015




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