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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065308

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NDA 065308 describes CEFUROXIME AXETIL, which is a drug marketed by Sun Pharm Inds Ltd, Alkem Labs Ltd, Ani Pharms Inc, Apotex, Aurobindo Pharma Ltd, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, and Wockhardt, and is included in eleven NDAs. It is available from twenty-seven suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.

The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for 065308

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

Pharmacology for NDA: 065308

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065308

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065308 ANDA NorthStar Rx LLC 16714-400 16714-400-02 60 TABLET in 1 BOTTLE (16714-400-02)
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065308 ANDA NorthStar Rx LLC 16714-400 16714-400-01 20 TABLET in 1 BOTTLE (16714-400-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 125MG BASE
Approval Date:Mar 29, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Mar 29, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Mar 29, 2006TE:ABRLD:No


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