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FDA Drug Application 019983 by AVEVA

Application Number019983
Application Type New Drug Application
Sponsor ApplicantAVEVA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/28/1992N       
AP05/13/1992SCM       
AP04/1/1993SCM       
AP02/2/1993SCS       
AP02/2/1993SCS       
AP01/26/1996SLR       
AP012/23/1998SCM1042011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf 12/23/1998
AP012/23/1998SCM1043011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm 12/23/1998
AP012/23/1998SE61045012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf 12/23/1998
AP012/23/1998SE61046012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm 12/23/1998
AP04/4/2000SCS       
AP05/7/2001SCS       
AP01/18/2002SLR4061016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983s16ltr.pdf 1/18/2002
AP01/18/2002SLR4062016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf 1/18/2002
AP010/4/2002SLR4060017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983slr017ltr.pdf 10/4/2002




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