Naphazoline hydrochloride; pheniramine maleate
Naphazoline hydrochloride; pheniramine maleate: 3 brands, 2 generics; first approved Jun 08, 1994; generic available.
Generic available: 2 ANDA applications approved.
Brand (NDA) products
- KENVUE BRANDSNDA 0204851996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025%;0.3% SOLUTION/DROPS OPHTHALMIC OTC - - ALCONNDA 0202261994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025%;0.3% SOLUTION/DROPS OPHTHALMIC OTC - - BAUSCH AND LOMBNDA 0200651994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02675%;0.315% SOLUTION/DROPS OPHTHALMIC OTC -
Generic (ANDA) products (2)
- RISINGANDA 2027952013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025%;0.3% SOLUTION/DROPS OPHTHALMIC OTC - - ALTAIRE PHARMS INCANDA 0782082010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02675%;0.315% SOLUTION/DROPS OPHTHALMIC OTC -
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.
Approval history
Approvals span 1994–2013 across 5 FDA applications.
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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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