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Details for New Drug Application (NDA): 040088

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NDA 040088 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Aurolife Pharma Llc, Vistapharm, Roxane, Mallinckrodt, The Pharmanetwork, Sandoz, Mallinckrodt Inc, and Corepharma, and is included in eighteen NDAs. It is available from sixteen 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 NDA: 040088

methadone hydrochloride
Therapeutic Class:Analgesics

Pharmacology for NDA: 040088

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 040088

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methadone hydrochloride
CONCENTRATE;ORAL 040088 ANDA VistaPharm Inc 66689-694 66689-694-30 30 mL in 1 BOTTLE, DROPPER (66689-694-30)
methadone hydrochloride
CONCENTRATE;ORAL 040088 ANDA VistaPharm Inc 66689-694 66689-694-79 1000 mL in 1 BOTTLE (66689-694-79)

Summary for product number 001

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

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