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AMIODARONE HYDROCHLORIDE

ANDA

AMIODARONE HYDROCHLORIDE | A075389 | DR REDDYS LABORATORIES SA

3 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Jan 25, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 25, 2001

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 2017

#003 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 2017