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Last Updated: July 21, 2024

Details for New Drug Application (NDA): 204550

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NDA 204550 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Acella, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Mylan, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc, and is included in thirty 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-one suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 204550
Applicant:Eugia Pharma
Ingredient:amiodarone hydrochloride
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:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Oct 25, 2017TE:RLD:No

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