← FDA DRUG APPROVALS

FDA NDA · NDA020377

CORDARONE

Sponsor: WYETH PHARMS INC

APPLICATION
NDA020377
TYPE
NDA
ORIGINAL APPROVAL
1995-08-03
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CORDARONE · ReferenceDiscontinued
AMIODARONE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2009-03-13Labeling · Supplement 19 · standardAP
2009-03-13Efficacy · Supplement 11 · standardAP
2006-08-28Labeling · Supplement 20 · standard — Letter ↗AP
2005-09-15Labeling · Supplement 18 · standard — Letter ↗AP
2004-11-04Labeling · Supplement 7 · standard — Letter ↗AP
2004-11-04Labeling · Supplement 15 · standard — Letter ↗AP
2004-11-04Labeling · Supplement 8 · standard — Letter ↗AP
2004-11-02Labeling · Supplement 17 · standard — Letter ↗AP
2004-09-02Labeling · Supplement 16 · standard — Letter ↗AP
2003-05-09Labeling · Supplement 12 · standard — Letter ↗AP
2003-05-09Labeling · Supplement 10 · standard — Letter ↗AP
2003-05-06Labeling · Supplement 13 · standard — Letter ↗AP
2003-05-06Labeling · Supplement 14 · standard — Letter ↗AP
2002-04-11Manufacturing (CMC) · Supplement 9 · standardAP
2001-07-11Labeling · Supplement 5 · standard — Letter ↗AP
2001-07-11Labeling · Supplement 4 · standard — Letter ↗AP
2001-05-02Manufacturing (CMC) · Supplement 6 · standardAP
1998-05-14Manufacturing (CMC) · Supplement 3 · standardAP
1997-12-10Labeling · Supplement 2 · standard — Review ↗AP
1995-10-18Labeling · Supplement 1 · standard — Review ↗AP
1995-08-03Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
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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