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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Cantor Fitzgerald
US Department of Justice
Medtronic
Queensland Health
McKesson
Federal Trade Commission
Teva

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087393

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NDA 087393 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Vistapharm, West-ward Pharms Int, Akorn, Mylan Institutional, Mallinckrodt Inc, Sandoz, Specgx Llc, Aurolife Pharma Llc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in twenty-one 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-two suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 087393
Tradename:METHADONE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:methadone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 087393
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 087393
Suppliers and Packaging for NDA: 087393
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087393 ANDA West-Ward Pharmaceuticals Corp. 0054-3555 N 0054-3555-63
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087393 ANDA Atlantic Biologicals Corps 17856-3555 N 17856-3555-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
Daiichi Sankyo
Express Scripts
Fuji
Deloitte
Colorcon
Accenture
AstraZeneca

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