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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 018299

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NDA 018299 describes VIROPTIC, which is a drug marketed by Monarch Pharms and is included in one NDA. Additional details are available on the VIROPTIC profile page.

The generic ingredient in VIROPTIC is trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trifluridine profile page.

Summary for 018299

Tradename:	VIROPTIC
Applicant:	Monarch Pharms
Ingredient:	trifluridine
Patents:	0

Medical Subject Heading (MeSH) Categories for 018299

Antimetabolites
Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	Yes

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