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Generated: December 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090707

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NDA 090707 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Vistapharm, West-ward Pharms Int, Akorn, Mylan Institutional, Mallinckrodt Inc, Specgx Llc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in twenty-two 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 090707
Tradename:METHADONE HYDROCHLORIDE
Applicant:Vistapharm
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090707
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 090707
Suppliers and Packaging for NDA: 090707
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 090707 ANDA VistaPharm, Inc. 66689-711 66689-711-16 500 mL in 1 BOTTLE (66689-711-16)
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 090707 ANDA VistaPharm, Inc. 66689-712 66689-712-16 500 mL in 1 BOTTLE (66689-712-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Jun 30, 2010TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Jun 30, 2010TE:AARLD:No

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