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

Summary for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Jan 7, 2011TE:RLD:No
Patent:6,759,059Patent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:6,761,910Patent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:7,910,132Patent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER


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