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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 020985


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NDA 020985 describes CARAC, which is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from two suppliers. 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. Fifteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 020985
Tradename:CARAC
Applicant:Valeant Pharms North
Ingredient:fluorouracil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020985
Medical Subject Heading (MeSH) Categories for 020985
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 Bausch Health US, LLC 0187-5200 0187-5200-30 1 TUBE in 1 CARTON (0187-5200-30) > 30 g in 1 TUBE
CARAC fluorouracil CREAM;TOPICAL 020985 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-8078 0378-8078-49 1 TUBE in 1 CARTON (0378-8078-49) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.5%
Approval Date:Oct 27, 2000TE:RLD:Yes

Expired US Patents for NDA 020985

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 See Plans and Pricing See Plans and Pricing
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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