APPLICATION
ANDA076362
TYPE
ANDA
ORIGINAL APPROVAL
2002-11-29
LATEST ACTION
2020-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 300MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 400MG · TABLET · ORAL
Approval history
2020-06-23Labeling · Supplement 25 · standardAP
2019-08-15Labeling · Supplement 19 · standardAP
2019-08-15Labeling · Supplement 18 · standardAP
2019-08-15Labeling · Supplement 22 · standardAP
2015-10-19Labeling · Supplement 17 · standardAP
2015-10-19Labeling · Supplement 16 · standardAP
2014-12-21Labeling · Supplement 14 · standardAP
2013-05-31Labeling · Supplement 11AP
2013-05-31Labeling · Supplement 10AP
2010-02-04Labeling · Supplement 9AP
2009-06-02Labeling · Supplement 8AP
2008-12-05Labeling · Supplement 7AP
2005-06-07Labeling · Supplement 6AP
2003-12-03Supplement · Supplement 1AP
2003-12-02Labeling · Supplement 2AP
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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