Is there a generic for Apraclonidine hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Apraclonidine hydrochloride, referencing the brand IOPIDINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Apraclonidine hydrochloride?

IOPIDINE (NDA 020258, HARROW EYE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Apraclonidine hydrochloride are approved?

Apraclonidine hydrochloride is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Apraclonidine hydrochloride

Apraclonidine hydrochloride is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:IOPIDINE · NDA 020258

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
IOPIDINERLD	HARROW EYE	NDA 020258	AT	Jul 30, 1993
IOPIDINERLD	HARROW EYE	NDA 019779	—	Dec 31, 1987

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
APRACLONIDINE HYDROCHLORIDE	RISING	ANDA 077764	AT	Mar 12, 2009

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.

Apraclonidine hydrochloride — frequently asked questions

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

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