Daliresp
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: 2011
Approved
Approval ID
c9a1d0a8-581f-4f91-a2b8-f419192d0ebf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 12, 2020
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
roflumilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0088
Application NumberNDA022522
Product Classification
M
Marketing Category
C73594
G
Generic Name
roflumilast
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2020
FDA Product Classification
INGREDIENTS (5)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
roflumilastActive
Quantity: 250 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
roflumilast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0095
Application NumberNDA022522
Product Classification
M
Marketing Category
C73594
G
Generic Name
roflumilast
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2020
FDA Product Classification
INGREDIENTS (5)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
roflumilastActive
Quantity: 500 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT