Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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. 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:1
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 Americas, Inc. 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 Spear Dermatology Products Inc 66530-258 66530-258-30 30 g in 1 TUBE (66530-258-30)
Paragraph IV (Patent) Challenges for 020985
Tradename Dosage Ingredient NDA Submissiondate
CARAC CREAM;TOPICAL fluorouracil 020985 2011-07-29

Profile for product number 001

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

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