Buprenorphine / Naloxone Oral Strip

Brand(s)
Suboxone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Reckitt Benckiser Pharmaceuticals Inc (2015-09-24)
Oldest Current Product
2010-09-13
License(s)
NDA
RxNORM
ORAL STRIP\BUPRENORPHINE:NALOXONE
FDAOB
BUCCAL, SUBLINGUAL\FILM\BUPRENORPHINE HYDROCHLORIDE: NALOXONE HYDROCHLORIDE\rdfq
SPL Active
SUBLINGUAL\FILM, SOLUBLE\BUPRENORPHINE HYDROCHLORIDE: NALOXONE HYDROCHLORIDE
SPL Moiety
SUBLINGUAL\FILM, SOLUBLE\BUPRENORPHINE: NALOXONE

product(s) by strength(s)

buprenorphine 12 mg / naloxone 3 mg oral strip

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1124961212SuboxoneNDAReckitt Benckiser Pharmaceuticals Inc2012-08-24BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDESUBLINGUALFILM, SOLUBLENDA0224108a5edcf9-828c-4f97-b671-268ab13a8ecd

buprenorphine 2 mg / naloxone 0.5 mg oral strip

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1124961202SuboxoneNDAReckitt Benckiser Pharmaceuticals Inc2010-09-13BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDESUBLINGUALFILM, SOLUBLENDA0224108a5edcf9-828c-4f97-b671-268ab13a8ecd

buprenorphine 4 mg / naloxone 1 mg oral strip

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1124961204SuboxoneNDAReckitt Benckiser Pharmaceuticals Inc2012-08-24BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDESUBLINGUALFILM, SOLUBLENDA0224108a5edcf9-828c-4f97-b671-268ab13a8ecd

buprenorphine 8 mg / naloxone 2 mg oral strip

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1124961208SuboxoneNDAReckitt Benckiser Pharmaceuticals Inc2010-09-13BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDESUBLINGUALFILM, SOLUBLENDA0224108a5edcf9-828c-4f97-b671-268ab13a8ecd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545696399SuboxoneNDAA-S Medication Solutions Llc2010-09-13BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDESUBLINGUALFILM, SOLUBLE124961208NDA022410426a0094-f192-48ff-be40-c4f7c9566d50
2557000147SuboxoneNDALake Erie Medical Dba Quality Care Products Llc2010-09-13BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDESUBLINGUALFILM, SOLUBLE124961208NDA022410b96582d7-6cb3-40b6-bf06-48ebd101014b

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1NDA022410SUBOXONEINDIVIOR INC2010-08-30p8017150, SUBSTANCE
p8475832, THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE, SUBSTANCE
p8603514, TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION, SUBSTANCE
NDA022410_001, NDA022410_002, NDA022410_003, NDA022410_004Buprenorphine / Naloxone Sublingual Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022410_001RXNALOXONE HYDROCHLORIDE (EQ 0.5MG BASE), BUPRENORPHINE HYDROCHLORIDE (EQ 2MG BASE)FILMFalse2010-08-30SUBOXONE
2NDA022410_002RXBUPRENORPHINE HYDROCHLORIDE (EQ 8MG BASE), NALOXONE HYDROCHLORIDE (EQ 2MG BASE)FILMFalse2010-08-30SUBOXONE
3NDA022410_003RXNALOXONE HYDROCHLORIDE (EQ 1MG BASE), BUPRENORPHINE HYDROCHLORIDE (EQ 4MG BASE)FILMFalse2012-08-10SUBOXONE
4NDA022410_004RXBUPRENORPHINE HYDROCHLORIDE (EQ 12MG BASE), NALOXONE HYDROCHLORIDE (EQ 3MG BASE)FILMTrue2012-08-10SUBOXONE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8017150 (view patent)2023-02-13NDA022410Buprenorphine / Naloxone Sublingual Tablet
2p8475832 (view patent)2030-03-26NDA022410Buprenorphine / Naloxone Sublingual Tablet
3p8603514 (view patent)2024-04-03NDA022410Buprenorphine / Naloxone Sublingual Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1426a0094-f192-48ff-be40-c4f7c9566d50 (view SPL)These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film.SUBOXONE (buprenorphine and naloxone) sublingual filmfor sublingual administration CIIIInitial U.S. Approval: 2002prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-06-121545696399
28a5edcf9-828c-4f97-b671-268ab13a8ecd (view SPL)These highlights do not include all the information needed to use SUBOXONE safely and effectively. See full prescribing information for SUBOXONE.SUBOXONE (buprenorphine and naloxone) sublingual film,for sublingual or buccal use CIIIInitial U.S. Approval: 2002prescriptionHuman PrescriptionReckitt Benckiser Pharmaceuticals IncAPI MANUFACTURE, MANUFACTURE, PACK2015-09-249124961202, 124961204, 124961208, 124961212
3b96582d7-6cb3-40b6-bf06-48ebd101014b (view SPL)These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film.SUBOXONE (buprenorphine and naloxone) sublingual filmfor sublingual administration CIIIInitial U.S. Approval: 2002prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2014-09-041557000147

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