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SELEGILINE HYDROCHLORIDE

ANDA

SELEGILINE HYDROCHLORIDE | A075352 | NOVITIUM PHARMA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs8 inactive

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

EUROAPI HUNGARY LTDSELEGILINE HYDROCHLORIDE

DMF 51611983

DIPHARMA FRANCIS SRLSELEGILINE HYDROCHLORIDE

DMF 92751991

CATALENT UK SWINDON ZYDIS LTDSELEGILINE HYDROCHLORIDE ZYDIS TABLET 1.25MG

DMF 159142002

WYCKOFF CHEMICAL CO INCInactiveSELEGILINE HYDROCHLORIDE

DMF 92301991

ALCHYMARS SPAInactiveSELEGILINE HYDROCHLORIDE

DMF 97341992

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 102351993

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHInactiveSELEGILINE HYDROCHLORIDE

DMF 103401993

IROTEC LABORATORIESInactiveSELEGILINE HYDROCHLORIDE

DMF 105291993

SIEGFRIED LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 111041994

RESOLUTION CHEMICALS LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 113561995

FARMAK ASInactiveSELEGILINE HYDROCHLORIDE USP

DMF 310242016

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 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 30, 1998

No patent or exclusivity listings for this strength.