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FDA Drug Application 076394 by PAR STERILE PRODUCTS

Application Number076394
Application Type Abbreviated New Drug Application
Sponsor ApplicantPAR STERILE PRODUCTS
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
AP04/25/2003N7409000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76394_Amiodarone Hydrochloride_Approv.pdf 12/24/2003
AP04/25/2003N7410000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/76394_Amiodarone Hydrochloride_Prntlbl.pdf 12/24/2003
AP04/25/2003N7411000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/076394_amiodarone-hydrochloride_toc.cfm 12/24/2003
AP04/25/2003N12318000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 7/28/2005




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