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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Johnson and Johnson
Fish and Richardson

Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050672

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NDA 050672 describes CEFTIN, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from one supplier. Additional details are available on the CEFTIN profile page.

The generic ingredient in CEFTIN is cefuroxime axetil. There are sixty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.
Summary for 050672
Ingredient:cefuroxime axetil
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050672
Suppliers and Packaging for NDA: 050672
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTIN cefuroxime axetil FOR SUSPENSION;ORAL 050672 NDA GlaxoSmithKline LLC 0173-0740 N 0173-0740-00
CEFTIN cefuroxime axetil FOR SUSPENSION;ORAL 050672 NDA GlaxoSmithKline LLC 0173-0741 N 0173-0741-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Jun 30, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Apr 29, 1997TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim

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