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CORDARONE

NDA

AMIODARONE HYDROCHLORIDE | N020377 | WYETH PHARMACEUTICALS INC

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

No clinical trials found on ClinicalTrials.gov for this drug

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

13 letters from Drugs@FDA

Date	Submission	Document
Sep 18, 2006	SUPPL -20	View Letter (PDF)
Sep 22, 2005	SUPPL -18	View Letter (PDF)
Nov 8, 2004	SUPPL -7	View Letter (PDF)
Nov 8, 2004	SUPPL -8	View Letter (PDF)
Nov 8, 2004	SUPPL -15	View Letter (PDF)
Nov 8, 2004	SUPPL -17	View Letter (PDF)
Sep 3, 2004	SUPPL -16	View Letter (PDF)
May 30, 2003	SUPPL -10	View Letter (PDF)
May 30, 2003	SUPPL -12	View Letter (PDF)
May 30, 2003	SUPPL -13	View Letter (PDF)
May 30, 2003	SUPPL -14	View Letter (PDF)
Jul 11, 2001	SUPPL -5	View Letter (PDF)
Jul 11, 2001	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 3, 1995

No patent or exclusivity listings for this strength.