You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075352

✉ Email this page to a colleague

« Back to Dashboard

NDA 075352 describes SELEGILINE HYDROCHLORIDE, which is a drug marketed by Apotex, Lannett Co Inc, Novitium Pharma, Rising, Chartwell Molecules, Cosette, G And W Labs Inc, Kenton, MLV, and Quagen, and is included in fourteen NDAs. It is available from eleven 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. Twelve 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.