Last Updated: September 24, 2026

Details for New Drug Application (NDA): 207729

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NDA 207729 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 207729

Tradename:	TOLCAPONE
Applicant:	Alvogen
Ingredient:	tolcapone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 29, 2020	TE:		RLD:	No

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