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Serving leading biopharmaceutical companies globally:

Citi
Cipla
McKesson
Deloitte
Federal Trade Commission
Queensland Health
Boehringer Ingelheim
Julphar
Mallinckrodt
McKinsey

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050605

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NDA 050605 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-seven suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for NDA: 050605

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

Pharmacology for NDA: 050605

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 050605

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTIN
cefuroxime axetil
TABLET;ORAL 050605 NDA GlaxoSmithKline LLC 0173-0387 0173-0387-00 20 TABLET, FILM COATED in 1 BOTTLE (0173-0387-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 125MG BASE
Approval Date:Dec 28, 1987TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Dec 28, 1987TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Dec 28, 1987TE:ABRLD:Yes


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Fish and Richardson
Chubb
Medtronic
Federal Trade Commission
UBS
Cipla
Mallinckrodt
Covington
Colorcon

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