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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076217


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NDA 076217 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, Zhejiang Poly Pharm, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Norvium Bioscience, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc, and is included in thirty-one NDAs. It is available from thirty 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-three suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 076217
Tradename:AMIODARONE HYDROCHLORIDE
Applicant:Mylan Institutional
Ingredient:amiodarone hydrochloride
Patents:0
Suppliers and Packaging for NDA: 076217
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076217 ANDA Henry Schein, Inc 0404-9815 0404-9815-03 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 076217 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1358 51662-1358-1 1 VIAL, GLASS in 1 CARTON (51662-1358-1) / 18 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Oct 15, 2002TE:APRLD:No

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