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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 074081

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NDA 074081 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 074081

Tradename:	METHADONE HYDROCHLORIDE
Applicant:	Roxane
Ingredient:	methadone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 074081

Analgesics, Opioid
Antitussive Agents
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Apr 28, 1995	TE:		RLD:	No

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