Details for New Drug Application (NDA): 021479

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NDA 021479 describes ZELAPAR, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the ZELAPAR profile page.

The generic ingredient in ZELAPAR 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 021479

Tradename:	ZELAPAR
Applicant:	Bausch
Ingredient:	selegiline hydrochloride
Patents:	0

Pharmacology for NDA: 021479

Mechanism of Action	Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Suppliers and Packaging for NDA: 021479

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479	NDA	Bausch Health US, LLC	0187-0453	0187-0453-02	6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	1.25MG
Approval Date:	Jun 14, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021479

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479-001	Jun 14, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479-001	Jun 14, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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