Last Updated: June 17, 2026

Details for New Drug Application (NDA): 021222

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NDA 021222 describes SPECTRACEF, which is a drug marketed by Vansen Pharma and is included in one NDA. Additional details are available on the SPECTRACEF profile page.

The generic ingredient in SPECTRACEF is cefditoren pivoxil. There are six drug master file entries for this compound. Additional details are available on the cefditoren pivoxil profile page.

Summary for 021222

Tradename:	SPECTRACEF
Applicant:	Vansen Pharma
Ingredient:	cefditoren pivoxil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 29, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jul 21, 2008	TE:		RLD:	No

Expired US Patents for NDA 021222

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vansen Pharma	SPECTRACEF	cefditoren pivoxil	TABLET;ORAL	021222-002	Jul 21, 2008	4,839,350	⤷ Start Trial
Vansen Pharma	SPECTRACEF	cefditoren pivoxil	TABLET;ORAL	021222-001	Aug 29, 2001	4,839,350	⤷ Start Trial
Vansen Pharma	SPECTRACEF	cefditoren pivoxil	TABLET;ORAL	021222-002	Jul 21, 2008	5,958,915	⤷ Start Trial
Vansen Pharma	SPECTRACEF	cefditoren pivoxil	TABLET;ORAL	021222-001	Aug 29, 2001	5,958,915	⤷ Start Trial
Vansen Pharma	SPECTRACEF	cefditoren pivoxil	TABLET;ORAL	021222-001	Aug 29, 2001	4,918,068	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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