Roflumilast Oral Tablet

Brand(s)
Daliresp
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-07-01)
Oldest Current Product
2011-02-28
License(s)
NDA
RxNORM
ORAL TABLET\ROFLUMILAST
FDAOB
ORAL\TABLET\ROFLUMILAST
SPL Active
ORAL\TABLET\ROFLUMILAST
SPL Moiety
ORAL\TABLET\ROFLUMILAST

product(s) by strength(s)

roflumilast 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003100095DalirespNDAAstrazeneca Pharmaceuticals Lp2015-07-01ROFLUMILASTORALTABLETNDA022522c9a1d0a8-581f-4f91-a2b8-f419192d0ebf

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544625DalirespNDACardinal Health2011-02-28ROFLUMILASTORALTABLET004560095NDA0225227ac9cc61-b860-478a-92bf-8a54c89f5b32

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022522DALIRESPASTRAZENECA PHARMACEUTICALS LP2011-02-28p8618142, SUBSTANCE
p8536206, TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
p8604064, TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
p5712298, TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS, SUBSTANCE
p8431154, SUBSTANCE
NEW CHEMICAL ENTITY [2016-02-28]NDA022522_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022522_001RXROFLUMILAST (500MCG)ORALTABLETTrue2011-02-28DALIRESP

patent(s)

#idexpiration dateapplication(s)
1p5712298 (view patent)2020-01-27NDA022522
2p8431154 (view patent)2023-02-19NDA022522
3p8536206 (view patent)2024-03-08NDA022522
4p8604064 (view patent)2024-03-08NDA022522
5p8618142 (view patent)2024-03-08NDA022522

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17ac9cc61-b860-478a-92bf-8a54c89f5b32 (view SPL)These highlights do not include all the information needed to use DALIRESP safely and effectively. See full prescribing information for DALIRESP. DALIRESP (roflumilast) tabletsInitial U.S. Approval: 2011prescriptionHuman PrescriptionCardinal HealthREPACK2015-07-102551544625
295519b97-d0a6-4c9f-baf0-bc5da08296c7 (view SPL)These highlights do not include all the information needed to use DALIRESP safely and effectively. See full prescribing information for DALIRESP. DALIRESP (roflumilast) tabletsInitial U.S. Approval: 2011prescriptionHuman PrescriptionForest Laboratories, IncMANUFACTURE, PACK2014-09-1610004560095
3c9a1d0a8-581f-4f91-a2b8-f419192d0ebf (view SPL)These highlights do not include all the information needed to use DALIRESP safely and effectively. See full prescribing information for DALIRESP. DALIRESP (roflumilast) tabletsInitial U.S. Approval: 2011prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-07-011003100095

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