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Last Updated: September 26, 2021

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Details for New Drug Application (NDA): 088109

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NDA 088109 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 088109
Ingredient:methadone hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 088109
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 088109
Suppliers and Packaging for NDA: 088109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 088109 ANDA Hikma Pharmaceuticals USA Inc. 0054-0710 0054-0710-20 1 BLISTER PACK in 1 CARTON (0054-0710-20) > 100 TABLET in 1 BLISTER PACK
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 088109 ANDA Hikma Pharmaceuticals USA Inc. 0054-0710 0054-0710-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-0710-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 8, 1983TE:AARLD:No

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