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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075761

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NDA 075761 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Teva Pharms Usa, Wockhardt, Apotex Inc, Mayne Pharma Inc, Murty Pharms, Mylan, Sandoz, Taro Pharm, Teva, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-nine NDAs. It is available from thirty-two 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-six suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for 075761

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075761

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 075761 ANDA General Injectables and Vaccines, Inc. 52584-616 52584-616-03 1 VIAL, SINGLE-DOSE in 1 BAG (52584-616-03) > 3 mL in 1 VIAL, SINGLE-DOSE
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 075761 ANDA APP Pharmaceuticals, LLC 63323-616 63323-616-03 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) > 3 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

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


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