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Details for New Drug Application (NDA): 017116

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NDA 017116 describes METHADOSE, which is a drug marketed by Mallinckrodt and Mallinckrodt Inc and is included in three NDAs. It is available from four 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 NDA: 017116

methadone hydrochloride
Therapeutic Class:Analgesics

Pharmacology for NDA: 017116

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 017116

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

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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