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FDA Drug Application 075594 by AESGEN

Application Number075594
Application Type Abbreviated New Drug Application
Sponsor ApplicantAESGEN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/6/2002N5234000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75594.ta.pdf 4/14/2003
AP05/6/2002N12083000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075594.pdf 7/22/2005
AP05/6/2002N18705000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
TA111/28/2001TA5234000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75594.ta.pdf 4/14/2003
TA111/28/2001TA12083000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075594.pdf 7/22/2005
TA111/28/2001TA18705000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008




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