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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 two suppliers. 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

Summary for NDA: 022259

Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022259

Suppliers and Packaging for NDA: 022259

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CREAM;TOPICAL 022259 NDA HILL DERMACEUTICALS, INC. 28105-421 28105-421-40 1 TUBE in 1 CARTON (28105-421-40) > 40 g in 1 TUBE
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength4%
Approval Date:Sep 18, 2015TE:RLD:Yes
Patent:7,169,401Patent Expiration:Jul 18, 2023Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 18, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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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.