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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 050672

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NDA 050672 describes CEFTIN, which is a drug marketed by Glaxosmithkline and is included in two NDAs. Additional details are available on the CEFTIN profile page.

The generic ingredient in CEFTIN is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for 050672

Tradename:	CEFTIN
Applicant:	Glaxosmithkline
Ingredient:	cefuroxime axetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Jun 30, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 250MG BASE/5ML
Approval Date:	Apr 29, 1997	TE:		RLD:	Yes

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