Roflumilast
These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
4d25f69c-58b7-4e2a-b835-4d0c76a83c7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2022
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-201
Application NumberANDA208256
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 28, 2019
Generic NameRoflumilast
INGREDIENTS (5)
ROFLUMILASTActive
Quantity: 250 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Roflumilast
PRODUCT DETAILS
NDC Product Code72205-200
Application NumberANDA208256
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 28, 2019
Generic NameRoflumilast
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ROFLUMILASTActive
Quantity: 500 ug in 1 1
Code: 0P6C6ZOP5U
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT