Fentanyl Nasal Spray

Brand(s)
Lazanda
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Archimedes Pharma Us Inc. (2012-07-30)
Oldest Current Product
2011-10-17
License(s)
NDA
RxNORM
NASAL SPRAY\FENTANYL
FDAOB
NASAL\SPRAY, METERED\FENTANYL CITRATE
SPL Active
NASAL\SPRAY\FENTANYL CITRATE
SPL Moiety
NASAL\SPRAY\FENTANYL

product(s) by strength(s)

fentanyl 0.1 mg/actuat nasal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1517720311LazandaNDAArchimedes Pharma Us Inc.2011-10-17FENTANYL CITRATENASALSPRAYNDA02256939531d0c-db12-4627-81c9-6563076b637b

fentanyl 0.4 mg/actuat nasal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1517720314LazandaNDAArchimedes Pharma Us Inc.2011-10-17FENTANYL CITRATENASALSPRAYNDA02256939531d0c-db12-4627-81c9-6563076b637b

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022569LAZANDADEPOMED INC2011-06-30p8889176, MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
p6432440, MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT CANCER PAIN, SUBSTANCE
p9078814, SUBSTANCE
p8216604, MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
NDA022569_001, NDA022569_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022569_001RXFENTANYL CITRATE (EQ 0.1MG BASE)NASALSPRAY, METEREDFalse2011-06-30LAZANDA
2NDA022569_002RXFENTANYL CITRATE (EQ 0.4MG BASE)NASALSPRAY, METEREDTrue2011-06-30LAZANDA

patent(s)

#idexpiration dateapplication(s)
1p6432440 (view patent)2018-04-20NDA022569
2p8216604 (view patent)2024-10-03NDA022569
3p8889176 (view patent)2024-01-16NDA022569
4p9078814 (view patent)2024-01-08NDA022569

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
139531d0c-db12-4627-81c9-6563076b637b (view SPL)These highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda (Fentanyl) Nasal Spray CIIInitial U.S. Approval: 1968prescriptionHuman PrescriptionArchimedes Pharma Us Inc.2012-07-305517720311, 517720314
29dcaff31-1653-11e3-8ffd-0800200c9a66 (view SPL)These highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda (Fentanyl) Nasal Spray CIIInitial U.S. Approval: 1968prescriptionHuman PrescriptionDepomed, Inc.LABEL, MANUFACTURE, PACK2014-12-313139130009, 139130010

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