APPLICATION
ANDA076394
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-25
LATEST ACTION
2006-05-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2006-05-12Labeling · Supplement 8AP
2005-08-26Labeling · Supplement 7AP
2005-06-09Labeling · Supplement 6AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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