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METHADONE HYDROCHLORIDE

ANDA

METHADONE HYDROCHLORIDE | A040180 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: METHADOSE(TE code: AA)

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 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Apr 30, 1998

No patent or exclusivity listings for this strength.