Buprenorphine / Naloxone Buccal Film

Brand(s)
Bunavail
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Biodelivery Sciences International, Inc. (2014-08-05)
Oldest Current Product
2014-08-05
License(s)
NDA
RxNORM
BUCCAL FILM\BUPRENORPHINE:NALOXONE
FDAOB
BUCCAL\FILM\BUPRENORPHINE HYDROCHLORIDE: NALOXONE HYDROCHLORIDE
SPL Active
BUCCAL\FILM\BUPRENORPHINE HYDROCHLORIDE: NALOXONE HYDROCHLORIDE DIHYDRATE
SPL Moiety
BUCCAL\FILM\BUPRENORPHINE: NALOXONE

product(s) by strength(s)

buprenorphine 2.1 mg / naloxone 0.3 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1593850012BunavailNDABiodelivery Sciences International, Inc.2014-08-05BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATEBUCCALFILMNDA20563712b963dd-f189-11e3-ac10-0800200c9a66

buprenorphine 4.2 mg / naloxone 0.7 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1593850014BunavailNDABiodelivery Sciences International, Inc.2014-08-05BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATEBUCCALFILMNDA20563712b963dd-f189-11e3-ac10-0800200c9a66

buprenorphine 6.3 mg / naloxone 1 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1593850016BunavailNDABiodelivery Sciences International, Inc.2014-08-05BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATEBUCCALFILMNDA20563712b963dd-f189-11e3-ac10-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205637BUNAVAILBIODELIVERY SCIENCES INTERNATIONAL INC2014-06-06p6159498, SUBSTANCE
p7579019, MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
p8147866, MAINTENANCE TREATMENT OF OPIOID DEPENDENCE, SUBSTANCE
p8703177, SUBSTANCE
NEW PRODUCT [2017-06-06]NDA205637_001, NDA205637_002, NDA205637_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205637_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 2.1MG BASE), NALOXONE HYDROCHLORIDE (EQ 0.3MG BASE)BUCCALFILMFalse2014-06-06BUNAVAIL
2NDA205637_002RXNALOXONE HYDROCHLORIDE (EQ 0.7MG BASE), BUPRENORPHINE HYDROCHLORIDE (EQ 4.2MG BASE)BUCCALFILMFalse2014-06-06BUNAVAIL
3NDA205637_003RXNALOXONE HYDROCHLORIDE (EQ 1MG BASE), BUPRENORPHINE HYDROCHLORIDE (EQ 6.3MG BASE)BUCCALFILMTrue2014-06-06BUNAVAIL

patent(s)

#idexpiration dateapplication(s)
1p6159498 (view patent)2016-10-18NDA205637, NDA022266
2p7579019 (view patent)2020-01-22NDA205637, NDA022266
3p8147866 (view patent)2027-07-23NDA205637
4p8703177 (view patent)2032-08-20NDA205637

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
112b963dd-f189-11e3-ac10-0800200c9a66 (view SPL)These highlights do not include all the information needed to use BUNAVAIL safely and effectively. See full prescribing information for BUNAVAIL. BUNAVAIL (buprenorphine and naloxone) buccal film, CIII Initial U.S. Approval: 2002prescriptionHuman PrescriptionBiodelivery Sciences International, Inc.2014-08-053593850012, 593850014, 593850016

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