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METHADONE HYDROCHLORIDE

ANDA

METHADONE HYDROCHLORIDE | A208305 | SUN PHARMACEUTICAL INDUSTRIES INC

2 strengths0 unique patents0 unique exclusivities

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
Apr 5, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 30, 2018

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 30, 2018