APPLICATION
ANDA075389
TYPE
ANDA
ORIGINAL APPROVAL
2001-01-25
LATEST ACTION
2019-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 100MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 400MG · TABLET · ORAL
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
Approval history
2019-11-21Labeling · Supplement 12 · standardAP
2008-02-21Labeling · Supplement 8AP
2007-04-12Labeling · Supplement 7AP
2007-03-07Labeling · Supplement 6AP
2005-05-03Labeling · Supplement 4AP
2002-08-28Labeling · Supplement 3AP
2002-08-23Manufacturing (CMC) · 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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