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METHADONE HYDROCHLORIDE

NDA

METHADONE HYDROCHLORIDE | N006383 | MALLINCKRODT INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs3 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED USA LLCMETHADONE HYDROCHLORIDE USP

DMF 62311986

CHATTEM CHEMICALS INCMETHADONE HYDROCHLORIDE USP

DMF 252862012

SPECGX LLCMETHADONE HYDROCHLORIDE USP

DMF 293502015

MALLINCKRODT INCInactiveMETHADONE HYDROCHLORIDE

DMF 15151970

ADAMHA NIDAInactiveMETHADONE

DMF 22241974

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETHADONE HYDROCHLORIDE USP

DMF 139421999

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 2, 2018	SUPPL -18	View Letter (PDF)
Dec 19, 2016	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 50GM/BOT

0 patents0 exclusivities▴

POWDER;FOR RX COMPOUNDING | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 100GM/BOT

0 patents0 exclusivities▾

POWDER;FOR RX COMPOUNDING | Approved: Approved Prior to Jan 1, 1982

#004 — 500GM/BOT

0 patents0 exclusivities▾

POWDER;FOR RX COMPOUNDING | Approved: Approved Prior to Jan 1, 1982