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Serving leading biopharmaceutical companies globally:

Argus Health
Julphar
Federal Trade Commission
Teva
US Department of Justice
Cerilliant
Express Scripts
AstraZeneca
Deloitte
Daiichi Sankyo

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040088

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NDA 040088 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Vistapharm, West-ward Pharms Int, Akorn, Mylan Institutional, Mallinckrodt Inc, Sandoz, Aurolife Pharma Llc, Epic Pharma Llc, Mallinckrodt, Roxane, and The Pharmanetwork, and is included in twenty NDAs. It is available from eighteen suppliers. Additional details are available on the METHADONE HYDROCHLORIDE profile page.

The generic ingredient in METHADONE HYDROCHLORIDE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 040088
Tradename:METHADONE HYDROCHLORIDE
Applicant:Vistapharm
Ingredient:methadone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 040088
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 040088
Suppliers and Packaging for NDA: 040088
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 040088 ANDA VistaPharm, Inc. 66689-694 66689-694-79 1000 mL in 1 BOTTLE (66689-694-79)
METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 040088 ANDA VistaPharm, Inc. 66689-694 66689-694-30 30 mL in 1 BOTTLE, DROPPER (66689-694-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength10MG/ML
Approval Date:Nov 30, 1994TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Covington
Fuji
Healthtrust
US Department of Justice
Julphar
Mallinckrodt
McKinsey
Accenture
Argus Health

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