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Last Updated: September 29, 2020

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Details for New Drug Application (NDA): 040517

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NDA 040517 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Specgx Llc, Vistapharm, Akorn, Mylan Institutional, Mallinckrodt Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Nostrum Labs Inc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in twenty-six 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 040517
Tradename:METHADONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040517
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 040517
Suppliers and Packaging for NDA: 040517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040517 ANDA SpecGx LLC 0406-5755 0406-5755-01 100 TABLET in 1 BOTTLE (0406-5755-01)
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040517 ANDA SpecGx LLC 0406-5755 0406-5755-23 1 TABLET in 1 BLISTER PACK (0406-5755-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 27, 2004TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 27, 2004TE:AARLD:No

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