Is there a generic for Emedastine difumarate?

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

What is the reference-listed drug for Emedastine difumarate?

EMADINE (NDA 020706, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Emedastine difumarate are approved?

Emedastine difumarate is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Emedastine difumarate

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

Reference-listed drug:EMADINE · NDA 020706

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
EMADINERLD	NOVARTIS	NDA 020706	—	Dec 29, 1997

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.

Emedastine difumarate — frequently asked questions

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

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