Make Better Decisions

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Chinese Patent Office
Healthtrust
McKesson
Merck
Daiichi Sankyo
Medtronic
Dow
Chubb

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020985

« Back to Dashboard

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 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)

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
Teva
Express Scripts
Cerilliant
McKinsey
Mallinckrodt
Julphar
Healthtrust
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot