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Serving leading biopharmaceutical companies globally:

Chubb
US Army
Novartis
Healthtrust
Chinese Patent Office
McKinsey
QuintilesIMS
US Department of Justice
Medtronic
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022510

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NDA 022510 describes ABSTRAL, which is a drug marketed by Sentynl Theraps Inc and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ABSTRAL profile page.

The generic ingredient in ABSTRAL is fentanyl citrate. There are thirty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 022510
Tradename:ABSTRAL
Applicant:Sentynl Theraps Inc
Ingredient:fentanyl citrate
Patents:3
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 022510
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 022510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510 NDA Sentynl Therapeutics, Inc. 42358-100 42358-100-32 8 BLISTER PACK in 1 CARTON (42358-100-32) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510 NDA Sentynl Therapeutics, Inc. 42358-200 42358-200-32 8 BLISTER PACK in 1 CARTON (42358-200-32) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Jan 7, 2011TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:➤ SubscribePatent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:➤ SubscribePatent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

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Serving leading biopharmaceutical companies globally:

Deloitte
Cipla
Fuji
Queensland Health
QuintilesIMS
Fish and Richardson
Merck
McKinsey
Cerilliant

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