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Last Updated: April 17, 2024

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE - Generic Drug Details


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What are the generic drug sources for naphazoline hydrochloride; pheniramine maleate and what is the scope of freedom to operate?

Naphazoline hydrochloride; pheniramine maleate is the generic ingredient in four branded drugs marketed by Altaire Pharms Inc, Rising, Alcon, Bausch And Lomb, and Johnson And Johnson, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Recent Clinical Trials for NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
EMSPhase 3

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US Patents and Regulatory Information for NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb OPCON-A naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 020065-001 Jun 8, 1994 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 202795-001 Jan 24, 2013 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon NAPHCON-A naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 020226-001 Jun 8, 1994 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Johnson And Johnson VISINE naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 020485-001 Jan 31, 1996 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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