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Last Updated: August 2, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065208


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NDA 065208 describes CEFPROZIL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Teva, and Wockhardt, and is included in fifteen NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the cefprozil profile page.
Summary for 065208
Tradename:CEFPROZIL
Applicant:Teva
Ingredient:cefprozil
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065208
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFPROZIL cefprozil TABLET;ORAL 065208 ANDA Teva Pharmaceuticals USA, Inc. 0093-1077 0093-1077-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-1077-01)
CEFPROZIL cefprozil TABLET;ORAL 065208 ANDA Teva Pharmaceuticals USA, Inc. 0093-1078 0093-1078-53 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 6, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 6, 2005TE:ABRLD:No

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