← FDA DRUG APPROVALS

FDA NDA · NDA018972

CORDARONE

Sponsor: WYETH PHARMS

APPLICATION
NDA018972
TYPE
NDA
ORIGINAL APPROVAL
1985-12-24
LATEST ACTION
2018-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CORDARONE · ReferenceDiscontinued
AMIODARONE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-10-17Labeling · Supplement 54 · standardLabelAP
2017-04-07Labeling · Supplement 53 · standardLabelAP
2016-11-22Labeling · Supplement 52 · standardLetterAP
2016-04-22Labeling · Supplement 51 · standardLabelAP
2015-03-27Labeling · Supplement 47 · unknownLabelAP
2014-12-22Labeling · Supplement 50 · standardLetterAP
2014-01-22Labeling · Supplement 48 · standardLetterAP
2014-01-17Manufacturing (CMC) · Supplement 49 · priorityAP
2012-11-20Manufacturing (CMC) · Supplement 46 · priorityAP
2011-11-14Labeling · Supplement 44 · unknownLetterAP
2010-12-13Labeling · Supplement 42 · unknownLabelAP
2009-11-19Labeling · Supplement 41 · unknownLabelAP
2009-09-28Labeling · Supplement 40 · standardLetterAP
2009-04-21Labeling · Supplement 39 · standardLabelAP
2009-04-21Labeling · Supplement 38 · standardLabelAP
2008-10-17Labeling · Supplement 37 · standardLetterAP
2007-11-13Labeling · Supplement 36 · standardLetterAP
2007-10-02Labeling · Supplement 35 · standardLetterAP
2007-03-30Labeling · Supplement 34 · standardLetterAP
2006-09-21Labeling · Supplement 32 · standardLetterAP
2006-08-28Labeling · Supplement 33 · standardLetterAP
2005-08-23Labeling · Supplement 31 · standardLetterAP
2004-12-03Labeling · Supplement 30 · standardReviewAP
2004-11-01Labeling · Supplement 29 · standardLetterAP
2004-09-02Labeling · Supplement 28 · standardLetterAP
2004-05-21Labeling · Supplement 27 · standardLetterAP
2004-05-21Labeling · Supplement 22 · standardLetterAP
2003-05-06Labeling · Supplement 26 · standardLetterAP
2003-04-30Labeling · Supplement 23 · standardLetterAP
2002-12-18Labeling · Supplement 25 · standardLetterAP
2002-09-20Manufacturing (CMC) · Supplement 24 · priorityAP
2001-12-18Labeling · Supplement 21 · standardAP
1999-10-08Labeling · Supplement 20 · standardReviewAP
1999-10-08Labeling · Supplement 19 · standardReviewAP
1999-01-05Labeling · Supplement 17 · standardLetterAP
1999-01-05Labeling · Supplement 15 · standardReviewAP
1998-06-15Labeling · Supplement 18 · standardReviewAP
1998-06-15Labeling · Supplement 16 · standardReviewAP
1995-10-18Labeling · Supplement 14 · standardReviewAP
1994-04-14Labeling · Supplement 12AP
VIEW ON DRUGS@FDA ↗

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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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