Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208305

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NDA 208305 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 nineteen suppliers. Additional details are available on the METHADONE HYDROCHLORIDE profile page.

The generic ingredient in METHADONE HYDROCHLORIDE is methadone hydrochloride. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

Summary for 208305

Tradename:	METHADONE HYDROCHLORIDE
Applicant:	Sun Pharm Industries
Ingredient:	methadone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 208305

Analgesics, Opioid
Antitussive Agents
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 30, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 30, 2018	TE:		RLD:	No

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