Details for New Drug Application (NDA): 204584

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NDA 204584 describes TOLCAPONE, which is a drug marketed by Alvogen, Dr Reddys Labs Sa, Endo Operations, and Novast Labs, 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 are five drug master file entries 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:	Endo Operations
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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