Podofilox
Content Updated: June 2018
Approved
Approval ID
e4a1e4c4-46b5-4059-8075-951c2347a7a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-8832
Application NumberNDA019795
Product Classification
M
Marketing Category
C73605
G
Generic Name
Podofilox
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (4)
PODOFILOXActive
Quantity: 5 mg in 1 mL
Code: L36H50F353
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT