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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065257

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NDA 065257 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 065257
Tradename:CEFPROZIL
Applicant:Sandoz
Ingredient:cefprozil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065257
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFPROZIL cefprozil FOR SUSPENSION;ORAL 065257 ANDA Sandoz Inc 0781-6202 0781-6202-57 75 mL in 1 BOTTLE (0781-6202-57)
CEFPROZIL cefprozil FOR SUSPENSION;ORAL 065257 ANDA Sandoz Inc 0781-6202 0781-6202-91 50 mL in 1 BOTTLE (0781-6202-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Dec 8, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Dec 8, 2005TE:ABRLD:No

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