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Generated: November 17, 2018

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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 two suppliers. 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. Fourteen 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 AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-1150 0093-1150-28 28 BLISTER PACK in 1 CARTON (0093-1150-28) > 1 TABLET in 1 BLISTER PACK (0093-1150-19)
FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-1151 0093-1151-28 28 BLISTER PACK in 1 CARTON (0093-1151-28) > 1 TABLET in 1 BLISTER PACK (0093-1151-19)

Profile for product number 001

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

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