APPLICATION
ANDA075135
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-30
LATEST ACTION
2019-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PACERONEPrescription
AMIODARONE HYDROCHLORIDE 100MG · TABLET · ORAL
PACERONEPrescription
AMIODARONE HYDROCHLORIDE 400MG · TABLET · ORAL
PACERONEPrescription
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
Approval history
2019-11-01Labeling · Supplement 49 · standardAP
2019-11-01Labeling · Supplement 51 · standardAP
2019-11-01Labeling · Supplement 35AP
2019-11-01Labeling · Supplement 27AP
2019-11-01Labeling · Supplement 54 · standardAP
2019-11-01Labeling · Supplement 52 · standardAP
2019-11-01Labeling · Supplement 26AP
2015-08-13Labeling · Supplement 47 · standardAP
2015-08-13Labeling · Supplement 45 · standardAP
2015-08-13Labeling · Supplement 48 · standardAP
2015-08-13Labeling · Supplement 46 · standardAP
2013-06-17Labeling · Supplement 43AP
2013-06-17Labeling · Supplement 44AP
2010-11-30Labeling · Supplement 41AP
2009-12-01Labeling · Supplement 40AP
2009-04-28Labeling · Supplement 39AP
2007-11-16Labeling · Supplement 34AP
2006-04-04Labeling · Supplement 25AP
2006-02-13Labeling · Supplement 18AP
2005-04-12Labeling · Supplement 11AP
2004-10-04Labeling · Supplement 17AP
2004-01-05Labeling · Supplement 16AP
2003-09-24Labeling · Supplement 13AP
2002-12-19Manufacturing (CMC) · Supplement 9AP
2002-08-20Labeling · Supplement 8AP
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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