NDA 20377, held by Wyeth Pharms Inc. Amiodarone Hydrochloride.
As of Nov 14, 2026, NDA 20377 (Cordarone), held by Wyeth Pharms Inc, was first approved by FDA on Aug 3, 1995, with 20 approved supplements and 0 published complete response letters.
| Mar 13, 2009 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 3, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cordarone50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Amiodarone Hydrochloride | DiscontinuedReference drug |
| Mar 13, 2009 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 13, 2009 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 28, 2006 | Supplement 20Labeling · Standard review | Approved | |
| Sep 15, 2005 | Supplement 18Labeling · Standard review | Approved | |
| Nov 4, 2004 | Supplement 15Labeling · Standard review | Approved | |
| Nov 4, 2004 | Supplement 8Labeling · Standard review | Approved | |
| Nov 4, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Nov 2, 2004 | Supplement 17Labeling · Standard review | Approved | |
| Sep 2, 2004 | Supplement 16Labeling · Standard review | Approved | |
| May 9, 2003 | Supplement 12Labeling · Standard review | Approved | |
| May 9, 2003 | Supplement 10Labeling · Standard review | Approved | |
| May 6, 2003 | Supplement 14Labeling · Standard review | Approved | |
| May 6, 2003 | Supplement 13Labeling · Standard review | Approved | |
| Apr 11, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 11, 2001 | Supplement 5Labeling · Standard review | Approved | |
| Jul 11, 2001 | Supplement 4Labeling · Standard review | Approved | |
| May 2, 2001 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 14, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1997 | Supplement 2Labeling · Standard review | Approved | |
| Oct 18, 1995 | Supplement 1Labeling · Standard review | Approved | |
| Aug 3, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
