APPLICATION
ANDA077161
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-20
LATEST ACTION
2020-06-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2020-06-23Labeling · Supplement 10 · standardAP
2013-05-21Manufacturing (CMC) · Supplement 7AP
2010-07-30Labeling · Supplement 6AP
2009-11-20Labeling · Supplement 5AP
2009-01-15Labeling · Supplement 4AP
2008-08-22Labeling · Supplement 3AP
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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