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Generated: June 23, 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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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
methadone hydrochloride
TABLET;ORAL 090065 ANDA CorePharma, LLC 64720-213 64720-213-10 100 TABLET in 1 BOTTLE, PLASTIC (64720-213-10)
METHADONE HYDROCHLORIDE
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:

Julphar
Cantor Fitzgerald
Daiichi Sankyo
UBS
Johnson and Johnson
Cipla
Mallinckrodt
Express Scripts
Chinese Patent Office
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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