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Details for New Drug Application (NDA): 075315

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NDA 075315 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Hospira, Wockhardt, Sandoz, Mylan Institutional, Bedford, Taro, Zydus Pharms Usa Inc, Akorn, Hikma Farmaceutica, Teva Pharms, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Teva Pharms Usa, Murty Pharms, Apotex Corp, Hospira Inc, Ben Venue, Mylan, Swan Pharms Llc, Intl Medication Sys, Par Sterile Products, Teva, and Bedford Labs, and is included in twenty-eight NDAs. It is available from thirty-three 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-eight suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for NDA: 075315

Tradename:
AMIODARONE HYDROCHLORIDE
Applicant:
Sandoz
Ingredient:
amiodarone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075315

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET;ORAL 075315 ANDA Eon Labs, Inc. 0185-0144 0185-0144-05 500 TABLET in 1 BOTTLE (0185-0144-05)
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET;ORAL 075315 ANDA Eon Labs, Inc. 0185-0144 0185-0144-09 90 TABLET in 1 BOTTLE (0185-0144-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 23, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jun 30, 2000TE:ABRLD:No


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