Is there a generic for Fomivirsen sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Fomivirsen sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Fomivirsen sodium?

VITRAVENE PRESERVATIVE FREE (NDA 020961, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Fomivirsen sodium are approved?

Fomivirsen sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Fomivirsen sodium

Fomivirsen sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:VITRAVENE PRESERVATIVE FREE · NDA 020961

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
VITRAVENE PRESERVATIVE FREE	NOVARTIS	NDA 020961	—	Aug 26, 1998

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.

Fomivirsen sodium — frequently asked questions

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

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