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FDA Drug Application 050529 by ROSS LABS

Application Number050529
Application Type New Drug Application
Sponsor ApplicantROSS LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/29/1979N       
AP09/29/1992SE1       
AP09/29/1992SLR       
AP04/16/1991SCG       
AP03/11/1992SCS       
AP05/6/1993SCS       
AP06/21/1994SCS       
AP02/9/2004SLR7739033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50529slr033ltr.pdf 2/27/2004




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