Details for New Drug Application (NDA): 074672

NDA 074672 describes SELEGILINE HYDROCHLORIDE, which is a drug marketed by Apotex, Lannett Co Inc, Novitium Pharma, Rising, Apotex Inc, Chartwell Molecules, Cosette, Dash Pharms Natco, G And W Labs Inc, I3 Pharms, Kenton, and Norvium Bioscience, and is included in fourteen NDAs. It is available from ten suppliers. Additional details are available on the SELEGILINE HYDROCHLORIDE profile page.

The generic ingredient in SELEGILINE HYDROCHLORIDE is selegiline hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.

Summary for 074672

Tradename:	SELEGILINE HYDROCHLORIDE
Applicant:	I3 Pharms
Ingredient:	selegiline hydrochloride
Patents:	0

Pharmacology for NDA: 074672

Mechanism of Action

Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Suppliers and Packaging for NDA: 074672

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074672	ANDA	i3 Pharmaceuticals, LLC	72319-006	72319-006-02	60 TABLET in 1 BOTTLE (72319-006-02)
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074672	ANDA	A2A Integrated Pharmaceuticals	73141-006	73141-006-02	60 TABLET in 1 BOTTLE (73141-006-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 1, 1997	TE:	AB	RLD:	No

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