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FDA Drug Application 011340 by PHARM RES ASSOC

Application Number011340
Application Type New Drug Application
Sponsor ApplicantPHARM RES ASSOC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/25/1958N       
AP010/7/1977SCM       
AP06/4/1981SCM       
AP012/2/1988SLR       
AP08/21/1991SLR       
AP02/11/2000SCS       
AP011/9/2000SCM       
AP011/9/2000SCM       
AP011/9/2000SCM       
AP011/9/2000SCM       
AP011/9/2000SCM       
AP011/9/2000SCM       
AP04/17/2002SLR2381016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11340s16ltr.pdf 4/12/2002
AP04/17/2002SLR2382016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf 4/12/2002




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