Details for New Drug Application (NDA): 021947

✉ Email this page to a colleague

NDA 021947 describes FENTORA, which is a drug marketed by Cephalon and is included in one NDA. It is available from two suppliers. There are four 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. Ten 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:	4

Pharmacology for NDA: 021947

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 021947

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947	NDA AUTHORIZED GENERIC	Mayne Pharma	51862-634	51862-634-28	28 BLISTER PACK in 1 CARTON (51862-634-28) / 1 TABLET in 1 BLISTER PACK (51862-634-01)
FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947	NDA AUTHORIZED GENERIC	Mayne Pharma	51862-635	51862-635-28	28 BLISTER PACK in 1 CARTON (51862-635-28) / 1 TABLET in 1 BLISTER PACK (51862-635-01)

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:	⤷ Sign Up	Patent Expiration:	Jun 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jun 15, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 30, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021947

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-006	Mar 2, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.