Last Updated: November 13, 2026

Details for New Drug Application (NDA): 065428

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NDA 065428 describes CEFPROZIL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Chartwell Rx, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Alkem Labs Ltd, Teva, and Wockhardt, and is included in sixteen NDAs. It is available from seven suppliers. Additional details are available on the CEFPROZIL profile page.

The generic ingredient in CEFPROZIL is cefprozil. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefprozil profile page.

Summary for 065428

Tradename:	CEFPROZIL
Applicant:	Wockhardt
Ingredient:	cefprozil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jun 14, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 14, 2007	TE:		RLD:	No

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