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FDA Drug Application 075188 by MYLAN

Application Number075188
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN
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
AP02/24/1999N4384000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_Approv.pdf 2/24/1999
AP02/24/1999N4385000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf 2/24/1999
AP02/24/1999N8740000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone.cfm 5/27/2004
AP02/24/1999N12305000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 7/28/2005
AP07/21/1999SL       
AP02/18/2000SL       
AP05/20/2002SCC       




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