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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 089897


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NDA 089897 describes METHADONE HYDROCHLORIDE INTENSOL, which is a drug marketed by Hikma and is included in one NDA. It is available from two suppliers. Additional details are available on the METHADONE HYDROCHLORIDE INTENSOL profile page.

The generic ingredient in METHADONE HYDROCHLORIDE INTENSOL 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 089897
Tradename:METHADONE HYDROCHLORIDE INTENSOL
Applicant:Hikma
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089897
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 089897
Suppliers and Packaging for NDA: 089897
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHADONE HYDROCHLORIDE INTENSOL methadone hydrochloride CONCENTRATE;ORAL 089897 ANDA Hikma Pharmaceuticals USA 0054-0391 0054-0391-68 1000 mL in 1 BOTTLE (0054-0391-68)
METHADONE HYDROCHLORIDE INTENSOL methadone hydrochloride CONCENTRATE;ORAL 089897 ANDA Hikma Pharmaceuticals USA Inc. 0054-3553 0054-3553-44 30 mL in 1 BOTTLE, DROPPER (0054-3553-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength10MG/ML
Approval Date:Sep 6, 1988TE:AARLD:No

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