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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 075424


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NDA 075424 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-nine 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-two suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 075424
Tradename:AMIODARONE HYDROCHLORIDE
Applicant:Taro
Ingredient:amiodarone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075424
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075424 ANDA Major Pharmaceuticals 0904-6993 0904-6993-61 100 BLISTER PACK in 1 CARTON (0904-6993-61) / 1 TABLET in 1 BLISTER PACK
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075424 ANDA Golden State Medical Supply, Inc. 51407-873 51407-873-30 30 TABLET in 1 BOTTLE (51407-873-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Mar 30, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 18, 2002TE:ABRLD:No

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