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FDA Drug Application 009112 by RANBAXY

Application Number009112
Application Type New Drug Application
Sponsor ApplicantRANBAXY
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
AP04/29/1955N       
AP09/9/1983SPD       
AP06/30/1981SDS       
AP06/30/1982SCS       
AP06/30/1982SCS       
AP02/4/1983SCS       
AP03/15/1983SCP       
AP05/9/1983SCS       
AP08/9/1983SCF       
AP04/25/1984SCM       
AP06/12/1984SCM       
AP011/26/1984SCS       
AP04/24/1989SCF       
AP03/3/1987SCS       
AP06/5/1987SCP       
AP05/23/2002SCM       
AP06/26/2003SLR6027021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr021ltr.pdf 7/6/2003
AP06/26/2003SLR6086021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf 7/8/2003
AP07/10/2009SCP22971022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009112s022ltr.pdf 7/15/2009
AP010/8/2014SCM       




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