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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 204550

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NDA 204550 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Wockhardt, Mayne Pharma Inc, Murty Pharms, Mylan, Rubicon, Sandoz, Taro, Teva, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-nine NDAs. It is available from twenty-eight 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 suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 204550
Tradename:AMIODARONE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:amiodarone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204550
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 204550 ANDA AuroMedics Pharma LLC 55150-180 55150-180-03 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-180-03) > 3 mL in 1 VIAL, SINGLE-DOSE
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 204550 ANDA AuroMedics Pharma LLC 55150-181 55150-181-09 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09) > 9 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Oct 25, 2017TE:APRLD:No

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