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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 two suppliers. 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:
CEFTIN
Applicant:
Glaxosmithkline
Ingredient:
cefuroxime axetil
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)
CEFTIN
cefuroxime axetil
TABLET;ORAL 050605 NDA GlaxoSmithKline LLC 0173-0394 0173-0394-00 20 TABLET, FILM COATED in 1 BOTTLE (0173-0394-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 125MG BASE
Approval Date:Dec 28, 1987TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Dec 28, 1987TE:ABRLD:No

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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