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Last Updated: March 26, 2026

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

Suppliers and Packaging for NDA: 090857

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFPROZIL	cefprozil	TABLET;ORAL	090857	ANDA	Ascend Laboratories, LLC	67877-243	67877-243-50	50 TABLET, FILM COATED in 1 BOTTLE (67877-243-50)
CEFPROZIL	cefprozil	TABLET;ORAL	090857	ANDA	Ascend Laboratories, LLC	67877-244	67877-244-01	100 TABLET, FILM COATED in 1 BOTTLE (67877-244-01)

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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