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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075082

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NDA 075082 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 075082

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

Pharmacology for NDA: 075082

Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for 075082

Suppliers and Packaging for NDA: 075082

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET, FOR SUSPENSION;ORAL 075082 ANDA VistaPharm, Inc. 66689-898 66689-898-40 100 TABLET in 1 BOTTLE (66689-898-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength40MG
Approval Date:Mar 25, 1998TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

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Dow
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Covington

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