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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. Eighteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for NDA: 021947

Tradename:
FENTORA
Applicant:
Cephalon
Ingredient:
fentanyl citrate
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:No
Patent:7,862,832Patent Expiration:Jun 15, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:7,862,833Patent Expiration:Jun 15, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,092,832Patent Expiration:Dec 30, 2024Product Flag?YSubstance Flag?Delist Request?


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