APPLICATION
ANDA076163
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-05
LATEST ACTION
2020-06-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2020-06-22Labeling · Supplement 17 · standardAP
2011-03-15Labeling · Supplement 4AP
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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