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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
US Army
Farmers Insurance
Queensland Health
Fish and Richardson

Generated: August 17, 2017

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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 Aurolife Pharma Llc, Vistapharm, Roxane, Mallinckrodt, Mylan Institutional, The Pharmanetwork, Sandoz, Mallinckrodt Inc, West-ward Pharms Int, and Epic Pharma Llc, and is included in nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

Summary for NDA: 090065

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 090065

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 090065

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methadone hydrochloride
TABLET;ORAL 090065 ANDA CorePharma, LLC 64720-213 64720-213-10 100 TABLET in 1 BOTTLE, PLASTIC (64720-213-10)
methadone hydrochloride
TABLET;ORAL 090065 ANDA CorePharma, LLC 64720-214 64720-214-10 100 TABLET in 1 BOTTLE, PLASTIC (64720-214-10)

Summary for product number 001

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

Summary for product number 002

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

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
US Army
Argus Health
Express Scripts
US Department of Justice
Federal Trade Commission

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