APPLICATION
ANDA075761
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-15
LATEST ACTION
2020-05-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2020-05-04Labeling · Supplement 17 · standardAP
2007-10-22Labeling · Supplement 12AP
2005-10-21Labeling · Supplement 8AP
2004-10-20Labeling · Supplement 6AP
2003-11-24Labeling · 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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