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Podofilox

Content Updated: June 2018

Approved
Approval ID

affc1058-7355-4486-8b65-378fea6f9454

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2022

Manufacturers
FDA

Actavis Pharma, Inc.

DUNS: 119723554

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 Code0591-3204
Application NumberNDA019795
Product Classification
M
Marketing Category
C73605
G
Generic Name
Podofilox
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 17, 2023
FDA Product Classification

INGREDIENTS (4)

PODOFILOXActive
Quantity: 5 mg in 1 mL
Code: L36H50F353
Classification: ACTIB
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

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Podofilox - FDA Drug Approval Details