Is there a generic for Podofilox?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Podofilox, referencing the brand CONDYLOX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Podofilox?

CONDYLOX (NDA 020529, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Podofilox are approved?

Podofilox is approved in the following dosage forms: gel, solution.

FDA Orange Book · active-ingredient family

Podofilox

Podofilox is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CONDYLOX · NDA 020529

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel, solution

Product	Applicant	Application	TE	Approved
CONDYLOXRLD	ALLERGAN	NDA 020529	—	Mar 13, 1997
CONDYLOXRLD	TEVA BRANDED PHARM	NDA 019795	—	Dec 13, 1990

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
PODOFILOX	PADAGIS US	ANDA 211871	—	Nov 22, 2023
PODOFILOX	BAUSCH AND LOMB INC	ANDA 090184	—	Jul 21, 2010
PODOFILOX	PADAGIS US	ANDA 075600	—	Jan 29, 2002

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Podofilox — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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