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Generated: January 18, 2019

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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. Thirteen 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:9
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)

Profile for product number 001

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

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