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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
UBS
US Army
Medtronic
Baxter
Harvard Business School
Chubb
Express Scripts
Fish and Richardson

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040517

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NDA 040517 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 The Pharmanetwork, and is included in twenty-one NDAs. It is available from fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 040517
Tradename:METHADONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:methadone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 040517
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 040517
Suppliers and Packaging for NDA: 040517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040517 ANDA SpecGx LLC 0406-5755 N 0406-5755-62
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040517 ANDA SpecGx LLC 0406-5755 N 0406-5755-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 27, 2004TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 27, 2004TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
McKesson
Fish and Richardson
Daiichi Sankyo
QuintilesIMS
Chubb
Harvard Business School
Johnson and Johnson

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