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Last Updated: July 4, 2020

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 one supplier. 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. Ten 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:0
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
Paragraph IV (Patent) Challenges for 022510
Tradename Dosage Ingredient NDA Submissiondate
ABSTRAL TABLET;SUBLINGUAL fentanyl citrate 022510 2014-06-19

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Jan 7, 2011TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 0.2MG BASE
Approval Date:Jan 7, 2011TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 0.3MG BASE
Approval Date:Jan 7, 2011TE:RLD:Yes

Expired US Patents for NDA 022510

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 Jan 7, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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