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Generated: April 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022259

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NDA 022259 describes TOLAK, which is a drug marketed by Hill Dermaceuticals and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TOLAK profile page.

The generic ingredient in TOLAK is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
Summary for 022259
Applicant:Hill Dermaceuticals
Formulation / Manufacturing:see details
Pharmacology for NDA: 022259
Medical Subject Heading (MeSH) Categories for 022259
Suppliers and Packaging for NDA: 022259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLAK fluorouracil CREAM;TOPICAL 022259 NDA Pierre Fabre Pharmaceuticals, Inc. 64370-421 64370-421-40 1 TUBE in 1 CARTON (64370-421-40) > 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength4%
Approval Date:Sep 18, 2015TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 18, 2023Product Flag?YSubstance Flag?Delist Request?

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