Is there a generic for Naphazoline hydrochloride; pheniramine maleate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Naphazoline hydrochloride; pheniramine maleate, referencing the brand VISINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Naphazoline hydrochloride; pheniramine maleate?

VISINE (NDA 020485, KENVUE BRANDS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Naphazoline hydrochloride; pheniramine maleate are approved?

Naphazoline hydrochloride; pheniramine maleate is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Naphazoline hydrochloride; pheniramine maleate

Naphazoline hydrochloride; pheniramine maleate: 3 brands, 2 generics; first approved Jun 08, 1994; generic available.

Generic available

Generic status & protection

Generic available — 2 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

VISINERLDRS

KENVUE BRANDSNDA 0204851996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%;0.3%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

NAPHCON-ARLDRS

ALCONNDA 0202261994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%;0.3%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

OPCON-ARLDRS

BAUSCH AND LOMBNDA 0200651994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02675%;0.315%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

Abbreviated applications

Generic (ANDA) products (2)

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE

RISINGANDA 2027952013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%;0.3%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE

ALTAIRE PHARMS INCANDA 0782082010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02675%;0.315%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Jun 08, 1994

32 yr 7 mo ago

Most recent approval

Jan 24, 2013

13 yr 8 mo ago

Approvals span 1994–2013 across 5 FDA applications.

Brand (NDA) 360%

Generic (ANDA) 240%

Naphazoline hydrochloride; pheniramine maleate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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