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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 065351

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NDA 065351 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 eight 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. Eight suppliers are listed for this compound. Additional details are available on the cefprozil profile page.

Summary for 065351

Tradename:	CEFPROZIL
Applicant:	Apotex Inc
Ingredient:	cefprozil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Feb 29, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML
Approval Date:	Feb 29, 2012	TE:		RLD:	No

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