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Generated: March 18, 2018

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Details for New Drug Application (NDA): 090065

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NDA 090065 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Vistapharm, West-ward Pharms Int, Akorn, Mylan Institutional, Mallinckrodt Inc, Sandoz, Specgx Llc, Aurolife Pharma Llc, Epic Pharma Llc, Roxane, and The Pharmanetwork, and is included in twenty 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 suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 090065
Applicant:Epic Pharma Llc
Ingredient:methadone hydrochloride
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090065

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 18, 2015TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 18, 2015TE:AARLD:No

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