Last Updated: November 9, 2026

Details for New Drug Application (NDA): 204584

NDA 204584 describes TOLCAPONE, which is a drug marketed by Alvogen, Dr Reddys Labs Sa, Ingenus Pharms Llc, and Ph Health, and is included in four NDAs. It is available from one supplier. Additional details are available on the TOLCAPONE profile page.

The generic ingredient in TOLCAPONE is tolcapone. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the tolcapone profile page.

Summary for 204584

Tradename:	TOLCAPONE
Applicant:	Ph Health
Ingredient:	tolcapone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Mar 26, 2015	TE:		RLD:	No

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