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Argus Health
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Generated: June 24, 2018

DrugPatentWatch Database Preview

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. There is one patent protecting this drug and one Paragraph IV challenge. 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. Nineteen 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:1
Therapeutic Class:Dermatological Agents
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 Valeant Pharmaceuticals North America LLC 0187-5200 N 0187-5200-30
CARAC fluorouracil CREAM;TOPICAL 020985 NDA AUTHORIZED GENERIC Spear Dermatology Products Inc 66530-258 N 66530-258-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.5%
Approval Date:Oct 27, 2000TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSIS

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Daiichi Sankyo
Federal Trade Commission
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