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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 006383

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NDA 006383 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 006383
Tradename:METHADONE HYDROCHLORIDE
Applicant:Mallinckrodt Inc
Ingredient:methadone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 006383
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 006383
Suppliers and Packaging for NDA: 006383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383 NDA Mallinckrodt, Inc. 0406-1510 N 0406-1510-56
METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383 NDA Mallinckrodt, Inc. 0406-1510 N 0406-1510-57

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;FOR RX COMPOUNDINGStrength50GM/BOT
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;FOR RX COMPOUNDINGStrength100GM/BOT
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;FOR RX COMPOUNDINGStrength500GM/BOT
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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