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Last Updated: September 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210484

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NDA 210484 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 210484
Tradename:METHADONE HYDROCHLORIDE
Applicant:Nostrum Labs Inc
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210484
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 210484
Suppliers and Packaging for NDA: 210484
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 210484 ANDA Glenmark Pharmaceuticals, Inc., USA 68462-800 68462-800-01 100 TABLET in 1 BOTTLE, PLASTIC (68462-800-01)
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 210484 ANDA Glenmark Pharmaceuticals, Inc., USA 68462-801 68462-801-01 100 TABLET in 1 BOTTLE, PLASTIC (68462-801-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 2, 2018TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 2, 2018TE:AARLD:No

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