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Generated: January 23, 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. Eighteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 020985
Applicant:Valeant Pharms North
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:➤ Try a Free TrialPatent Expiration:Jun 2, 2021Product Flag?YSubstance Flag?Delist Request?

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