Visitor Monitoring Drug History: AMIODARONE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: AMIODARONE HYDROCHLORIDE
FDA Application No: (ANDA) 076394
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
Company: APOTEX INC
 
Label History
 
View the label approved on December 24, 2003 for AMIODARONE HYDROCHLORIDE, (ANDA) 076394


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/25/2003 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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