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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090707

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NDA 090707 describes METHADONE HYDROCHLORIDE, which is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Breckenridge, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Epic Pharma Llc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in twenty-nine 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. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

Summary for 090707

Tradename:	METHADONE HYDROCHLORIDE
Applicant:	Vistapharm Llc
Ingredient:	methadone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090707

Analgesics, Opioid
Antitussive Agents
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Jun 30, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	10MG/5ML
Approval Date:	Jun 30, 2010	TE:		RLD:	No

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