Is there a generic for Idoxuridine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Idoxuridine. It is available as 4 brand (NDA) applications.

What is the reference-listed drug for Idoxuridine?

DENDRID (NDA 014169, ALCON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Idoxuridine are approved?

Idoxuridine is approved in the following dosage forms: ointment, solution/drops.

FDA Orange Book · active-ingredient family

Idoxuridine

Idoxuridine is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DENDRID · NDA 014169

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · ointment, solution/drops

Product	Applicant	Application	TE	Approved
DENDRIDRLD	ALCON	NDA 014169	—	Approved Prior to Jan 1, 1982
STOXIL	GLAXOSMITHKLINE	NDA 015868	—	Approved Prior to Jan 1, 1982
HERPLEX	ALLERGAN	NDA 013935	—	Approved Prior to Jan 1, 1982
STOXIL	GLAXOSMITHKLINE	NDA 013934	—	Approved Prior to Jan 1, 1982

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.

Idoxuridine — frequently asked questions

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

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