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FDA Drug Application 018821 by ROBINS AH

Application Number018821
Application Type New Drug Application
Sponsor ApplicantROBINS AH
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
AP03/25/1983N       
AP07/5/1983SLR       
AP08/12/1983SCS       
AP09/23/1983SCS       
AP03/12/1985SLR       
AP08/20/1985SLR       
AP010/21/1985SLR       
AP04/23/1986SLR       
AP011/4/1986SCP       
AP010/21/1986SLR       
AP05/5/1987SLR       
AP08/31/1992SCS       
AP02/22/1989SLR       
AP05/31/1994SLR       
AP06/24/1996SLR       
AP06/1/2000SLR       
AP01/30/1998SCM       
AP03/9/1999SLR3128018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf 6/18/2001
AP011/7/2001SLR3125020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf 11/25/2002




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