Last Updated: June 17, 2026

Details for New Drug Application (NDA): 208306

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NDA 208306 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 are thirteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

Summary for 208306

Tradename:	METHADONE HYDROCHLORIDE
Applicant:	Long Grove Pharms
Ingredient:	methadone hydrochloride
Patents:	0

Pharmacology for NDA: 208306

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 208306

Analgesics, Opioid
Antitussive Agents
Narcotics

Suppliers and Packaging for NDA: 208306

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHADONE HYDROCHLORIDE	methadone hydrochloride	INJECTABLE;INJECTION	208306	ANDA	Long Grove Pharmaceuticals, LLC	81298-7500	81298-7500-1	1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Oct 27, 2017	TE:	AP	RLD:	No

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