You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 19, 2024

Details for New Drug Application (NDA): 075424

✉ Email this page to a colleague

« Back to Dashboard

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
Ingredient:amiodarone hydrochloride
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.