Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AstraZeneca
230790719
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Daliresp
Product Details
NDC Product Code
0310-0088Application Number
NDA022522Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 12, 2020starch, cornInactive
Code: O8232NY3SJClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
RoflumilastActive
Code: 0P6C6ZOP5UClass: ACTIBQuantity: 250 ug in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
Daliresp
Product Details
NDC Product Code
0310-0095Application Number
NDA022522Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 12, 2020starch, cornInactive
Code: O8232NY3SJClass: IACT
RoflumilastActive
Code: 0P6C6ZOP5UClass: ACTIBQuantity: 500 ug in 1 1
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT