APPLICATION
ANDA074739
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-30
LATEST ACTION
2020-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMIODARONE HYDROCHLORIDEPrescription
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL
Approval history
2020-06-24Labeling · Supplement 37 · standardAP
2020-06-24Labeling · Supplement 35 · standardAP
2020-06-24Labeling · Supplement 36 · standardAP
2015-09-24Labeling · Supplement 34 · standardAP
2015-04-06Labeling · Supplement 32 · standardAP
2015-04-06Labeling · Supplement 33 · standardAP
2013-05-31Labeling · Supplement 30AP
2011-03-22Labeling · Supplement 27AP
2010-01-08Labeling · Supplement 26AP
2009-07-22Labeling · Supplement 25AP
2009-01-16Labeling · Supplement 24AP
2008-07-14Labeling · Supplement 23AP
2008-03-12Labeling · Supplement 22AP
2007-08-30Labeling · Supplement 21AP
2007-04-30Labeling · Supplement 20AP
2006-08-07Labeling · Supplement 19AP
2006-04-04Labeling · Supplement 18AP
2005-05-11Labeling · Supplement 15AP
2002-05-24Labeling · Supplement 13AP
2001-04-11Manufacturing (CMC) · Supplement 12AP
2001-04-11Manufacturing (CMC) · Supplement 11AP
2000-12-07Manufacturing (CMC) · Supplement 10AP
2000-12-07Manufacturing (CMC) · Supplement 9AP
2000-12-07Manufacturing (CMC) · Supplement 8AP
2000-02-29Labeling · Supplement 7AP
1999-10-26Manufacturing (CMC) · Supplement 5AP
1999-09-02Labeling · Supplement 3AP
1999-09-02Manufacturing (CMC) · Supplement 1AP
1999-09-02Manufacturing (CMC) · Supplement 2AP
1999-03-23Manufacturing (CMC) · Supplement 4AP
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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