Details for New Drug Application (NDA): 075352

NDA 075352 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 075352

Tradename:	SELEGILINE HYDROCHLORIDE
Applicant:	Novitium Pharma
Ingredient:	selegiline hydrochloride
Patents:	0

Pharmacology for NDA: 075352

Mechanism of Action

Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Suppliers and Packaging for NDA: 075352

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075352	ANDA	Marlex Pharmaceuticals, Inc.	10135-737	10135-737-60	60 CAPSULE in 1 BOTTLE (10135-737-60)
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075352	ANDA	Novitium Pharma LLC	70954-504	70954-504-10	60 CAPSULE in 1 BOTTLE (70954-504-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Nov 30, 1998	TE:	AB	RLD:	No

Complete Access Available with Subscription