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Generated: July 27, 2017

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Details for New Drug Application (NDA): 077069

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NDA 077069 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Hospira, Wockhardt, Sandoz, Mylan Institutional, Bedford, Taro Pharm, Zydus Pharms Usa Inc, Akorn, Hikma Farmaceutica, Teva Pharms, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Teva Pharms Usa, Murty Pharms, Apotex Inc, Hospira Inc, Ben Venue, Mylan, Mayne Pharma Inc, Intl Medication Sys, Par Sterile Products, Teva, and Bedford Labs, and is included in twenty-eight NDAs. It is available from thirty-two suppliers. Additional details are available on the AMIODARONE HYDROCHLORIDE profile page.

The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for NDA: 077069

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077069

Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors

Suppliers and Packaging for NDA: 077069

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	077069	ANDA	Mayne Pharma Inc.	51862-154	51862-154-30	30 TABLET in 1 BOTTLE (51862-154-30)
AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	077069	ANDA	Mayne Pharma Inc.	51862-155	51862-155-60	60 TABLET in 1 BOTTLE (51862-155-60)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Apr 8, 2005	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Apr 8, 2005	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Oct 4, 2016	TE:	AB	RLD:	No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.