MedPath

Podophyllotoxin

Generic Name
Podophyllotoxin
Brand Names
Condylox
Drug Type
Small Molecule
Chemical Formula
C22H22O8
CAS Number
518-28-5
Unique Ingredient Identifier
L36H50F353

Overview

A lignan found in podophyllin resin from the roots of podophyllum plants. It is a potent spindle poison, toxic if taken internally, and has been used as a cathartic. It is very irritating to skin and mucous membranes, has keratolytic actions, has been used to treat warts and keratoses, and may have antineoplastic properties, as do some of its congeners and derivatives.

Indication

For treatment of external genital warts (Condyloma acuminatum).

Associated Conditions

  • External Genital Warts
  • Perianal Warts

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Padagis US LLC
0574-0621
TOPICAL
5 mg in 1 g
5/1/2023
Padagis US LLC
0574-0611
TOPICAL
5 mg in 1 mL
11/12/2018
Bryant Ranch Prepack
63629-8832
TOPICAL
5 mg in 1 mL
1/20/2022
Physicians Total Care, Inc.
54868-6198
TOPICAL
5 mg in 1 mL
11/15/2010
Actavis Pharma, Inc.
0591-3204
TOPICAL
5 mg in 1 mL
7/17/2023
Allergan, Inc.
0023-6118
TOPICAL
5 mg in 1 g
2/8/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
CONDYLINE Paint, bottle
35097
Medicine
A
2/7/1992

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CONDYLINE
sanofi-aventis canada inc
01945149
Solution - Topical
0.5 %
12/31/1992
WARTEC
STIEFEL LABORATORIES (IRELAND) LIMITED
02074788
Liquid - Topical
5 MG / ML
12/31/1995

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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