Last Updated: June 24, 2026

Details for New Drug Application (NDA): 021947

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NDA 021947 describes FENTORA, which is a drug marketed by Cephalon and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FENTORA profile page.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for 021947

Tradename:	FENTORA
Applicant:	Cephalon
Ingredient:	fentanyl citrate
Patents:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;BUCCAL, SUBLINGUAL			Strength	EQ 0.1MG BASE
Approval Date:	Sep 25, 2006	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jun 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Jun 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;BUCCAL, SUBLINGUAL			Strength	EQ 0.2MG BASE
Approval Date:	Sep 25, 2006	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jun 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021947

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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