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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 087393


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NDA 087393 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Vistapharm, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, 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. Seventeen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 087393
Tradename:METHADONE HYDROCHLORIDE
Applicant:Hikma
Ingredient:methadone hydrochloride
Patents:0
Pharmacology for NDA: 087393
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 087393
Suppliers and Packaging for NDA: 087393
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087393 ANDA Hikma Pharmaceuticals USA Inc. 0054-3555 0054-3555-63 500 mL in 1 BOTTLE (0054-3555-63)
METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087393 ANDA ATLANTIC BIOLOGICALS CORP. 17856-3554 17856-3554-1 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-1) / 5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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