Podofilox
Physician Information Podofilox Gel 0.5%
Approved
Approval ID
d2e70c5e-d4a9-4295-9eff-517ffb974e61
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2023
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Podofilox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-0621
Application NumberANDA211871
Product Classification
M
Marketing Category
C73584
G
Generic Name
Podofilox
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (7)
PODOFILOXActive
Quantity: 5 mg in 1 g
Code: L36H50F353
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT