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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017116

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NDA 017116 describes METHADOSE, which is a drug marketed by Mallinckrodt Inc and Mallinckrodt and is included in three NDAs. It is available from three suppliers. Additional details are available on the METHADOSE profile page.

The generic ingredient in METHADOSE 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 017116

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

Pharmacology for NDA: 017116

Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for 017116

Suppliers and Packaging for NDA: 017116

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADOSE methadone hydrochloride CONCENTRATE;ORAL 017116 NDA Mallinckrodt, Inc. 0406-0527 0406-0527-15 15000 mL in 1 BOTTLE, PLASTIC (0406-0527-15)
METHADOSE methadone hydrochloride CONCENTRATE;ORAL 017116 NDA Mallinckrodt, Inc. 0406-0527 0406-0527-10 1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength10MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes


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