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Serving leading biopharmaceutical companies globally:

Baxter
US Army
Cerilliant
Cipla
Federal Trade Commission
Deloitte
Dow
Healthtrust
Queensland Health
Daiichi Sankyo

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065381

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NDA 065381 describes CEFPROZIL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Teva, and Wockhardt, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the CEFPROZIL profile page.

The generic ingredient in CEFPROZIL is cefprozil. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cefprozil profile page.
Summary for 065381
Tradename:CEFPROZIL
Applicant:Aurobindo Pharma
Ingredient:cefprozil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065381
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFPROZIL cefprozil FOR SUSPENSION;ORAL 065381 ANDA NorthStar Rx LLC 16714-396 N 16714-396-03
CEFPROZIL cefprozil FOR SUSPENSION;ORAL 065381 ANDA NorthStar Rx LLC 16714-396 N 16714-396-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Jan 30, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Jan 30, 2007TE:ABRLD:No

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Fuji
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Chinese Patent Office
Covington
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