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Serving leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Teva
Argus Health
Julphar
Federal Trade Commission
Moodys
Accenture
UBS
Chinese Patent Office

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065135

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NDA 065135 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 065135
Tradename:CEFUROXIME AXETIL
Applicant:Lupin
Ingredient:cefuroxime axetil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065135
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065135 ANDA PD-Rx Pharmaceuticals, Inc. 43063-584 43063-584-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-584-20)
CEFUROXIME AXETIL cefuroxime axetil TABLET;ORAL 065135 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-785 49999-785-20 20 TABLET in 1 BOTTLE (49999-785-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jul 25, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jul 25, 2003TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
Accenture
QuintilesIMS
Merck
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UBS
Farmers Insurance
Fish and Richardson

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