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Last Updated: June 12, 2024

Details for New Drug Application (NDA): 017116

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NDA 017116 describes METHADOSE, which is a drug marketed by Specgx Llc and is included in three NDAs. It is available from two 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. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 017116
Applicant:Specgx Llc
Ingredient:methadone hydrochloride
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 SpecGx LLC 0406-0527 0406-0527-10 1000 mL in 1 BOTTLE, PLASTIC (0406-0527-10)
METHADOSE methadone hydrochloride CONCENTRATE;ORAL 017116 NDA SpecGx LLC 0406-8725 0406-8725-10 1000 mL in 1 BOTTLE, PLASTIC (0406-8725-10)

Profile 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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