Details for New Drug Application (NDA): 206803

NDA 206803 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 206803

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

Pharmacology for NDA: 206803

Mechanism of Action

Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Suppliers and Packaging for NDA: 206803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	206803	ANDA	Rising Pharma Holdings, Inc.	16571-659	16571-659-06	60 CAPSULE in 1 BOTTLE (16571-659-06)
SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	206803	ANDA	Rising Pharma Holdings, Inc.	16571-659	16571-659-50	500 CAPSULE in 1 BOTTLE (16571-659-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Apr 2, 2019	TE:	AB	RLD:	No

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