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CORDARONE

NDA

AMIODARONE HYDROCHLORIDE | N018972 | WYETH PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery NCT05543278	Phase 4	Not Yet Recruiting	Massachusetts General Hospital	242	2027-01 → 2028-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs5 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

PMC ISOCHEMAMIODARONE HYDROCHLORIDE

DMF 76171988

ALIVUS LIFE SCIENCES LTDAMIODARONE HYDROCHLORIDE USP

DMF 167872003

PIRAMAL PHARMA LTDAMIODARONE HYDROCHLORIDE

DMF 216942008

CTX LIFE SCIENCES PVT LTDAMIODARONE HYDROCHLORIDE USP

DMF 258922012

UNICHEM LABORATORIES LTDAMIODARONE HYDROCHLORIDE USP

DMF 336882019

HAINAN POLY PHARM CO LTDAMIODARONE HYDROCHLORIDE USP

DMF 361632021

EMCURE PHARMACEUTICALS LTDAMIODARONE HYDROCHLORIDE USP

DMF 381602023

SANOFI SYNTHELABO INCInactiveAMIODARONE HYDROCHLORIDE

DMF 49551983

LABORATOIRE CHOAYInactiveAMIODARONE HYDROCHLORIDE INJECTION

DMF 65291986

SHANGHAI SHENLONG PHARMACEUTICAL CO LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 141711999

AUROBINDO PHARMA LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 172172004

ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 245182010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

30 letters from Drugs@FDA

Date	Submission	Document
Oct 22, 2018	SUPPL -54	View Letter (PDF)
Apr 12, 2017	SUPPL -53	View Letter (PDF)
Nov 23, 2016	SUPPL -52	View Letter (PDF)
Apr 26, 2016	SUPPL -51	View Letter (PDF)
Mar 31, 2015	SUPPL -47	View Letter (PDF)
Dec 24, 2014	SUPPL -50	View Letter (PDF)
Jan 23, 2014	SUPPL -48	View Letter (PDF)
Nov 16, 2011	SUPPL -44	View Letter (PDF)
Dec 15, 2010	SUPPL -42	View Letter (PDF)
Jan 7, 2010	SUPPL -41	View Letter (PDF)
Nov 12, 2009	SUPPL -40	View Letter (PDF)
Apr 24, 2009	SUPPL -38	View Letter (PDF)
Apr 24, 2009	SUPPL -39	View Letter (PDF)
Oct 21, 2008	SUPPL -37	View Letter (PDF)
Nov 19, 2007	SUPPL -36	View Letter (PDF)
Oct 4, 2007	SUPPL -35	View Letter (PDF)
Apr 9, 2007	SUPPL -34	View Letter (PDF)
Sep 25, 2006	SUPPL -32	View Letter (PDF)
Sep 18, 2006	SUPPL -33	View Letter (PDF)
Aug 31, 2005	SUPPL -31	View Letter (PDF)
Dec 6, 2004	SUPPL -30	View Letter (PDF)
Nov 8, 2004	SUPPL -29	View Letter (PDF)
Sep 3, 2004	SUPPL -28	View Letter (PDF)
Jun 1, 2004	SUPPL -25	View Letter (PDF)
May 27, 2004	SUPPL -22	View Letter (PDF)
May 27, 2004	SUPPL -27	View Letter (PDF)
May 30, 2003	SUPPL -26	View Letter (PDF)
May 29, 2003	SUPPL -23	View Letter (PDF)
Jan 5, 1999	SUPPL -15	View Letter (PDF)
Jan 5, 1999	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 24, 1985

No patent or exclusivity listings for this strength.