Roflumilast
Roflumilast Tablets, for oral use
Approved
Approval ID
e87287bd-eae3-46c3-9072-04800aeabf40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Roflumilast
PRODUCT DETAILS
NDC Product Code70771-1673
Application NumberANDA208303
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameRoflumilast
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ROFLUMILASTActive
Quantity: 250 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
Roflumilast
PRODUCT DETAILS
NDC Product Code70771-1674
Application NumberANDA208303
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic NameRoflumilast
INGREDIENTS (8)
ROFLUMILASTActive
Quantity: 500 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT