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Serving leading biopharmaceutical companies globally:

Colorcon
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Argus Health
Express Scripts
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Medtronic
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Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016988

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NDA 016988 describes FLUOROPLEX, which is a drug marketed by Aqua Pharms and Elorac and is included in two NDAs. It is available from one supplier. Additional details are available on the FLUOROPLEX profile page.

The generic ingredient in FLUOROPLEX 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 016988
Tradename:FLUOROPLEX
Applicant:Aqua Pharms
Ingredient:fluorouracil
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 016988
Medical Subject Heading (MeSH) Categories for 016988
Suppliers and Packaging for NDA: 016988
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROPLEX fluorouracil CREAM;TOPICAL 016988 NDA Aqua Pharmaceuticals, LLC 16110-812 16110-812-30 1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Harvard Business School
Julphar
Covington
Mallinckrodt
Boehringer Ingelheim
US Army
Dow
Chinese Patent Office

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