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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Cerilliant
QuintilesIMS
Fish and Richardson
Accenture
Covington
Teva
Chinese Patent Office
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065355

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NDA 065355 describes SUPRAX, which is a drug marketed by Lupin Ltd, Lederle, and Lupin Pharms, and is included in eight NDAs. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SUPRAX profile page.

The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.

Summary for 065355

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065355

Ingredient-typeCephalosporins

Medical Subject Heading (MeSH) Categories for 065355

Suppliers and Packaging for NDA: 065355

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRAX cefixime FOR SUSPENSION;ORAL 065355 ANDA LUPIN PHARMA 27437-206 27437-206-04 1 BOTTLE in 1 CARTON (27437-206-04) > 10 mL in 1 BOTTLE
SUPRAX cefixime FOR SUSPENSION;ORAL 065355 ANDA LUPIN PHARMA 27437-206 27437-206-05 25 mL in 1 BOTTLE (27437-206-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Apr 10, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
Novartis
Fuji
Citi
Deloitte
McKinsey
AstraZeneca
Federal Trade Commission
Colorcon

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