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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 087997


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NDA 087997 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 087997
Tradename:METHADONE HYDROCHLORIDE
Applicant:Hikma
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087997
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 087997
Suppliers and Packaging for NDA: 087997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087997 ANDA Hikma Pharmaceuticals USA Inc. 0054-3556 0054-3556-63 500 mL in 1 BOTTLE (0054-3556-63)
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087997 ANDA ATLANTIC BIOLOGICALS CORP. 17856-3556 17856-3556-5 72 CUP in 1 CASE (17856-3556-5) / 10 mL in 1 CUP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Aug 30, 1982TE:AARLD:Yes

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