APPLICATION
ANDA075424
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-30
LATEST ACTION
2020-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2020-06-23Labeling · Supplement 31 · standardAP
2019-08-15Labeling · Supplement 23 · standardAP
2019-08-15Labeling · Supplement 28 · standardAP
2019-08-15Labeling · Supplement 24 · standardAP
2015-10-05Labeling · Supplement 21 · standardAP
2015-10-05Labeling · Supplement 22 · standardAP
2014-12-21Labeling · Supplement 19 · standardAP
2013-05-31Labeling · Supplement 17AP
2013-05-31Labeling · Supplement 16AP
2010-02-04Labeling · Supplement 14AP
2009-06-02Labeling · Supplement 13AP
2008-12-05Labeling · Supplement 12AP
2005-06-07Labeling · Supplement 8AP
2002-12-18Manufacturing (CMC) · Supplement 1AP
2002-12-18Manufacturing (CMC) · Supplement 4AP
2002-12-18Labeling · Supplement 2AP
2002-12-09Manufacturing (CMC) · Supplement 5AP
2002-12-09Manufacturing (CMC) · 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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