Famotidine / Ibuprofen Oral Tablet

Brand(s)
Duexis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Horizon Pharma, Inc. (2015-07-24)
Oldest Current Product
2011-04-29
License(s)
NDA
RxNORM
ORAL TABLET\FAMOTIDINE:IBUPROFEN
FDAOB
ORAL\TABLET\FAMOTIDINE: IBUPROFEN
SPL Active
ORAL\TABLET, COATED\FAMOTIDINE: IBUPROFEN
SPL Moiety
ORAL\TABLET, COATED\FAMOTIDINE: IBUPROFEN

product(s) by strength(s)

famotidine 26.6 mg / ibuprofen 800 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1759870010DuexisNDAHorizon Pharma, Inc.2011-04-29FAMOTIDINE, IBUPROFENORALTABLET, COATEDNDA022519558b9f26-37b2-423b-932d-25a37afe57ec

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022519DUEXISHORIZON PHARMA INC2011-04-23p8501228, RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
p8067033, SUBSTANCE
p8067451, RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS, SUBSTANCE
p8309127, SUBSTANCE
p8318202, SUBSTANCE
p8449910, SUBSTANCE
NDA022519_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022519_001RXFAMOTIDINE (26.6MG), IBUPROFEN (800MG)ORALTABLETTrue2011-04-23DUEXIS

patent(s)

#idexpiration dateapplication(s)
1p8067033 (view patent)2026-07-18NDA022519
2p8067451 (view patent)2026-07-18NDA022519
3p8309127 (view patent)2026-07-18NDA022519
4p8318202 (view patent)2026-07-18NDA022519
5p8449910 (view patent)2026-07-18NDA022519
6p8501228 (view patent)2026-07-18NDA022519

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1558b9f26-37b2-423b-932d-25a37afe57ec (view SPL)These highlights do not include all the information needed to use DUEXIS safely and effectively. See full prescribing information for DUEXIS. DUEXIS (ibuprofen and famotidine) tablets, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionHorizon Pharma, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, RELABEL2015-07-248759870010

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