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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 090857

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NDA 090857 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 are thirteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefprozil profile page.

Summary for 090857

Tradename:	CEFPROZIL
Applicant:	Alkem Labs Ltd
Ingredient:	cefprozil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Apr 9, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 9, 2024	TE:	AB	RLD:	No

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