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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020985

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NDA 020985 describes CARAC, which is a drug marketed by Extrovis and is included in one NDA. It is available from one supplier. Additional details are available on the CARAC profile page.

The generic ingredient in CARAC is fluorouracil. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

Summary for 020985

Tradename:	CARAC
Applicant:	Extrovis
Ingredient:	fluorouracil
Patents:	0

Medical Subject Heading (MeSH) Categories for 020985

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Suppliers and Packaging for NDA: 020985

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARAC	fluorouracil	CREAM;TOPICAL	020985	NDA AUTHORIZED GENERIC	Dr. Reddy's Laboratories Inc.	75907-169	75907-169-11	1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.5%
Approval Date:	Oct 27, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 020985

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	4,690,825	⤷ Get Started Free
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	6,670,335	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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