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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077142


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NDA 077142 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm, Long Grove Pharms, 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 eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 077142
Tradename:METHADONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077142
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 077142
Suppliers and Packaging for NDA: 077142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride TABLET, FOR SUSPENSION;ORAL 077142 ANDA SpecGx LLC 0406-2540 0406-2540-01 100 TABLET in 1 BOTTLE (0406-2540-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength40MG
Approval Date:Jul 12, 2005TE:AARLD:No

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