Details for New Drug Application (NDA): 074871

NDA 074871 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 074871

Tradename:	SELEGILINE HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	selegiline hydrochloride
Patents:	0

Pharmacology for NDA: 074871

Mechanism of Action

Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Suppliers and Packaging for NDA: 074871

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074871	ANDA	A-S Medication Solutions	50090-2918	50090-2918-0	4 TABLET in 1 BOTTLE (50090-2918-0)
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074871	ANDA	Golden State Medical Supply, Inc.	60429-176	60429-176-60	60 TABLET in 1 BOTTLE (60429-176-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 6, 1997	TE:	AB	RLD:	No

Complete Access Available with Subscription