Fentanyl Sublingual Tablet

Brand(s)
Abstral
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Galena Biopharma, Inc. (2014-11-30)
Oldest Current Product
2011-01-07
License(s)
NDA
RxNORM
SUBLINGUAL TABLET\FENTANYL
FDAOB
SUBLINGUAL\TABLET\FENTANYL CITRATE
SPL Active
SUBLINGUAL\TABLET\FENTANYL CITRATE
SPL Moiety
SUBLINGUAL\TABLET\FENTANYL

product(s) by strength(s)

fentanyl 0.1 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1427470221AbstralNDAProstrakan, Inc.2011-01-07FENTANYL CITRATESUBLINGUALTABLETNDA0225104906457e-30ad-4da7-b3ac-bb9e6651a670

fentanyl 0.2 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578810332AbstralNDAGalena Biopharma, Inc.2013-08-08FENTANYL CITRATESUBLINGUALTABLETNDA022510f969e2bc-6297-4e29-89d3-a3685a2c7c6b

fentanyl 0.3 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578810333AbstralNDAGalena Biopharma, Inc.2013-08-08FENTANYL CITRATESUBLINGUALTABLETNDA022510f969e2bc-6297-4e29-89d3-a3685a2c7c6b

fentanyl 0.4 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578810334AbstralNDAGalena Biopharma, Inc.2013-08-08FENTANYL CITRATESUBLINGUALTABLETNDA022510f969e2bc-6297-4e29-89d3-a3685a2c7c6b

fentanyl 0.6 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578810336AbstralNDAGalena Biopharma, Inc.2013-08-08FENTANYL CITRATESUBLINGUALTABLETNDA022510f969e2bc-6297-4e29-89d3-a3685a2c7c6b

fentanyl 0.8 mg sublingual tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578810338AbstralNDAGalena Biopharma, Inc.2013-08-08FENTANYL CITRATESUBLINGUALTABLETNDA022510f969e2bc-6297-4e29-89d3-a3685a2c7c6b

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022510ABSTRALGALENA BIOPHARMA2011-01-07p7910132, MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER, SUBSTANCE
p6761910, MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER, SUBSTANCE
p6759059, MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER, SUBSTANCE
NDA022510_001, NDA022510_002, NDA022510_003, NDA022510_004, NDA022510_005, NDA022510_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022510_001RXFENTANYL CITRATE (EQ 0.1MG BASE)SUBLINGUALTABLETFalse2011-01-07ABSTRAL
2NDA022510_002RXFENTANYL CITRATE (EQ 0.2MG BASE)SUBLINGUALTABLETFalse2011-01-07ABSTRAL
3NDA022510_003RXFENTANYL CITRATE (EQ 0.3MG BASE)SUBLINGUALTABLETFalse2011-01-07ABSTRAL
4NDA022510_004RXFENTANYL CITRATE (EQ 0.4MG BASE)SUBLINGUALTABLETTrue2011-01-07ABSTRAL
5NDA022510_005RXFENTANYL CITRATE (EQ 0.6MG BASE)SUBLINGUALTABLETFalse2011-01-07ABSTRAL
6NDA022510_006RXFENTANYL CITRATE (EQ 0.8MG BASE)SUBLINGUALTABLETFalse2011-01-07ABSTRAL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6759059 (view patent)2019-09-24NDA022510
2p6761910 (view patent)2019-09-24NDA022510, NDA021997zolpidem Sublingual Tablet
3p7910132 (view patent)2019-09-24NDA022510

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14906457e-30ad-4da7-b3ac-bb9e6651a670 (view SPL)These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionProstrakan, Inc.manufacture2012-02-293427470221
2f969e2bc-6297-4e29-89d3-a3685a2c7c6b (view SPL)These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionGalena Biopharma, Inc.MANUFACTURE2014-11-302578810332, 578810333, 578810334, 578810336, 578810338, 578810331

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII