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Moodys
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Generated: June 18, 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. Fifteen 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 N 42358-100-32
ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510 NDA Sentynl Therapeutics, Inc. 42358-200 N 42358-200-32

Profile for product number 001

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

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Queensland Health
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