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Last Updated: August 4, 2021

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Details for New Drug Application (NDA): 040180


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NDA 040180 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Lannett Co Inc, 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-eight NDAs. It is available from seventeen 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-one suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 040180
Tradename:METHADONE HYDROCHLORIDE
Applicant:Hikma
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040180
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 040180
Suppliers and Packaging for NDA: 040180
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 040180 ANDA Hikma Pharmaceuticals USA Inc. 0054-0392 0054-0392-68 1000 mL in 1 BOTTLE (0054-0392-68)
METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 040180 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0392 17856-0392-1 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) > .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength10MG/ML
Approval Date:Apr 30, 1998TE:AARLD:No

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