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FDA Drug Application 021961 by SYNTHON PHARMS

Application Number021961
Application Type New Drug Application
Sponsor ApplicantSYNTHON PHARMS
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
AP010/9/2007N18189000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021961s000ltr.pdf 10/10/2007
AP010/9/2007N18210000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021961lbl.pdf 10/10/2007
AP010/9/2007N21697000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021961_simvastatin_toc.cfm 2/2/2009
AP010/9/2007N28971000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm 5/26/2011




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