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PODOFILOX

ANDA

PODOFILOX | A075600 | PADAGIS US LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Oclassen Pharmaceuticals, Inc. (Kleinfeld, Kaplan and Becker) - Citizen Petition FDA-1992-P-0110 · 5 docket documents Oclassen Pharmaceuticals, Inc., through counsel at Kleinfeld, Kaplan and Becker, petitioned the FDA to recognize Condylox (podofilox) 0.5% Solution as entitled to five-year marketing exclusivity under sections 505(j)(4)(D)(ii) and 505(c)(3)(D)(ii) of the Federal Food, Drug, and Cosmetic Act and to a	Other	2009-06-19	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$15.81

per ml

Lowest NADAC/Unit

$15.81

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00574061105PODOFILOX 0.5% TOPICAL SOLN	$15.81	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$20.00

Highest Price

$20.00

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00574-0611-05PODOFILOX 0.5% SOLN,TOP	$20.00	FSS	Padagis Sourcing Solutions LLC	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

XIAN PHARMACEUTICAL FACTORYInactivePODOFILOX

DMF 101821993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Jan 29, 2002

No patent or exclusivity listings for this strength.