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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075321

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NDA 075321 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 075321

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

Pharmacology for NDA: 075321

Mechanism of Action	Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Suppliers and Packaging for NDA: 075321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075321	ANDA	Apotex Corp.	60505-0055	60505-0055-1	60 CAPSULE in 1 BOTTLE (60505-0055-1)
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075321	ANDA	Apotex Corp.	60505-0055	60505-0055-2	1000 CAPSULE in 1 BOTTLE (60505-0055-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Dec 4, 1998	TE:	AB	RLD:	No

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