Viewing data from:

METHADONE HYDROCHLORIDE

ANDA

METHADONE HYDROCHLORIDE | A208306 | LONG GROVE PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: METHADONE HYDROCHLORIDE(TE code: AP)

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

1 letter from Drugs@FDA

Date	Submission	Document
Nov 8, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 27, 2017

No patent or exclusivity listings for this strength.