APPLICATION
ANDA079029
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-16
LATEST ACTION
2019-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 400MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2019-10-29Labeling · Supplement 19 · standardAP
2019-10-29Labeling · Supplement 18 · standardAP
2019-10-29Labeling · Supplement 22 · standardAP
2019-10-29Labeling · Supplement 20 · standardAP
2015-10-06Labeling · Supplement 14 · standardAP
2015-03-09Labeling · Supplement 13 · standardAP
2015-03-09Labeling · Supplement 10 · standardAP
2013-08-16Labeling · Supplement 7 · standardAP
2013-05-31Labeling · Supplement 5AP
2013-05-31Labeling · Supplement 3AP
2010-08-31Labeling · Supplement 2AP
2009-07-10Labeling · 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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