APPLICATION
ANDA077069
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-08
LATEST ACTION
2020-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 400MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 100MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
Approval history
2020-07-15Labeling · Supplement 11 · standardAP
2020-07-15Labeling · Supplement 12 · standardAP
2020-07-15Labeling · Supplement 10 · standardAP
2015-05-19Labeling · Supplement 7 · standardAP
2015-05-19Labeling · Supplement 5 · standardAP
2015-05-19Labeling · Supplement 8 · standardAP
2013-05-31Labeling · Supplement 4 · standardAP
2007-04-11Labeling · 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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