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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019334

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NDA 019334 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 019334

Tradename:	SELEGILINE HYDROCHLORIDE
Applicant:	Norvium Bioscience
Ingredient:	selegiline hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 5, 1989	TE:		RLD:	Yes

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