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Serving leading biopharmaceutical companies globally:

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US Army
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Generated: November 19, 2017

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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. It is available from one supplier. There are nine 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. Seventeen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for 021947

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:9
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021947

Mechanism of ActionFull 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 Cephalon, Inc. 63459-541 63459-541-28 28 BLISTER PACK in 1 CARTON (63459-541-28) > 1 TABLET in 1 BLISTER PACK (63459-541-04)
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL 021947 NDA Cephalon, Inc. 63459-542 63459-542-28 28 BLISTER PACK in 1 CARTON (63459-542-28) > 1 TABLET in 1 BLISTER PACK (63459-542-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Sep 25, 2006TE:RLD:Yes
Patent:► SubscribePatent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:► SubscribePatent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:► SubscribePatent Expiration:Jun 15, 2028Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cerilliant
Merck
Moodys
Express Scripts
Colorcon
Citi
Chubb
Cantor Fitzgerald
Argus Health

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 verifification 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.

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