Fentanyl Mucosal Spray

Brand(s)
Subsys
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Insys Therapeutics, Inc. (2015-01-06)
Oldest Current Product
2012-03-13
License(s)
NDA
RxNORM
MUCOSAL SPRAY\FENTANYL
FDAOB
SUBLINGUAL\SPRAY\FENTANYL
SPL Active
SUBLINGUAL\SPRAY\FENTANYL
SPL Moiety
SUBLINGUAL\SPRAY\FENTANYL

product(s) by strength(s)

fentanyl 0.1 mg/actuat mucosal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1204820001SubsysNDAInsys Therapeutics, Inc.2012-03-13FENTANYLSUBLINGUALSPRAYNDA20278818a413e9-11e0-4a8f-86c0-d33b37b7b771

fentanyl 0.2 mg/actuat mucosal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1204820002SubsysNDAInsys Therapeutics, Inc.2012-03-13FENTANYLSUBLINGUALSPRAYNDA20278818a413e9-11e0-4a8f-86c0-d33b37b7b771

fentanyl 0.4 mg/actuat mucosal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1204820004SubsysNDAInsys Therapeutics, Inc.2012-03-13FENTANYLSUBLINGUALSPRAYNDA20278818a413e9-11e0-4a8f-86c0-d33b37b7b771

fentanyl 0.6 mg/actuat mucosal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1204820012SubsysNDAInsys Therapeutics, Inc.2012-08-30FENTANYLSUBLINGUALSPRAYNDA20278818a413e9-11e0-4a8f-86c0-d33b37b7b771

fentanyl 0.8 mg/actuat mucosal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1204820016SubsysNDAInsys Therapeutics, Inc.2012-08-30FENTANYLSUBLINGUALSPRAYNDA20278818a413e9-11e0-4a8f-86c0-d33b37b7b771

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202788SUBSYSINSYS THERAPEUTICS INC2012-01-04p8835459, SUBSTANCE
p8835460, TREATMENT OF PAIN, SUBSTANCE
p8486972, SUBSTANCE
p8486973, TREATMENT OF PAIN
NEW PRODUCT [2015-01-04]NDA202788_001, NDA202788_002, NDA202788_003, NDA202788_004, NDA202788_005, NDA202788_006, NDA202788_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202788_001RXFENTANYL (0.1MG)SUBLINGUALSPRAYFalse2012-01-04SUBSYS
2NDA202788_002RXFENTANYL (0.2MG)SUBLINGUALSPRAYFalse2012-01-04SUBSYS
3NDA202788_003RXFENTANYL (0.4MG)SUBLINGUALSPRAYTrue2012-01-04SUBSYS
4NDA202788_004RXFENTANYL (0.6MG)SUBLINGUALSPRAYFalse2012-01-04SUBSYS
5NDA202788_005RXFENTANYL (0.8MG)SUBLINGUALSPRAYFalse2012-01-04SUBSYS
6NDA202788_006RXFENTANYL (1.2MG)SUBLINGUALSPRAYFalse2012-08-30SUBSYS
7NDA202788_007RXFENTANYL (1.6MG)SUBLINGUALSPRAYFalse2012-08-30SUBSYS

patent(s)

#idexpiration dateapplication(s)
1p8486972 (view patent)2030-04-27NDA202788
2p8486973 (view patent)2030-04-27NDA202788
3p8835459 (view patent)2027-01-25NDA202788
4p8835460 (view patent)2027-01-25NDA202788

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
118a413e9-11e0-4a8f-86c0-d33b37b7b771 (view SPL)These highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS (fentanyl sublingual spray), CII Initial U.S. Approval: 1968prescriptionHuman PrescriptionInsys Therapeutics, Inc.2015-01-0612204820001, 204820002, 204820004, 204820012, 204820016, 204820006, 204820008

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