APPLICATION
ANDA075188
TYPE
ANDA
ORIGINAL APPROVAL
1999-02-24
LATEST ACTION
2008-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
Approval history
2008-06-12Labeling · Supplement 7AP
2005-05-05Labeling · Supplement 6AP
2004-08-06Labeling · Supplement 5AP
2002-05-20Manufacturing (CMC) · Supplement 4AP
2000-02-18Labeling · Supplement 3AP
1999-07-21Labeling · Supplement 1AP
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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