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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 065381

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NDA 065381 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 065381

Tradename:	CEFPROZIL
Applicant:	Aurobindo Pharma
Ingredient:	cefprozil
Patents:	0

Suppliers and Packaging for NDA: 065381

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFPROZIL	cefprozil	FOR SUSPENSION;ORAL	065381	ANDA	NorthStar Rx LLC	16714-396	16714-396-02	75 mL in 1 BOTTLE (16714-396-02)
CEFPROZIL	cefprozil	FOR SUSPENSION;ORAL	065381	ANDA	NorthStar Rx LLC	16714-396	16714-396-03	100 mL in 1 BOTTLE (16714-396-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	125MG/5ML
Approval Date:	Jan 30, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML
Approval Date:	Jan 30, 2007	TE:	AB	RLD:	No

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