`
`Drugs@FOA FDA-Approved Drugs
`
`Drugs@FDA: FDA-Approved Drugs
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`Home fjndex.cfml Previous Page
`
`New Drug Appl ication (NDA): 020485
`Company: JOHNSON AND JOHNSON
`
`Products on NPA 020485
`
`CSV Excel Print
`
`• EMAIi (Mlll ro-~
`SIIRJECJ-PffllCSffQA· EPA
`Af>PRPYfP PBJIC
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`% 26VARAPPlNQ=0 20485)
`
`Drug
`Name
`
`VISINE
`
`Active I ngredients
`
`Strength
`
`Dosage Form/ Route
`
`Marketing Status
`
`TE Code
`
`R L D
`
`RS
`
`NAPHAZOUNE HYDROCHLORIDE; PHENIRAMINE
`MALEATE
`
`0 .025%;0.3%
`
`SOLllTlON/DROPS;OPHTHALMIC
`
`Over-the-counter
`
`Y e s
`
`Showing 1 to 1 of 1 entries
`
`APnmval Patel~) and Histon.:,...L.ell.ell~ Reviews for NDA 920485
`
`I abels for NOA 029435
`
`Other OTC Dmos with the Same Active logwlimt....slwJfllh and Posa0 e EormJBoute
`
`VISINE
`
`The products listed here are over-the-counter (OTC) drugs and do not receive therapeut c equivalence ratings. They may not be interchangeable.
`
`SOLUTION/DROPS OPHTHALMIC 0.025o/o O.Jo/e
`
`csv Excel Print
`
`NAPHAZOUNE
`HYDROCHLORIDE AND
`PHENIRAMINE MALEATE
`
`NAPHAZOUNE
`HYDROCHLORIDE;
`PHENIRAMINE MALEATE
`
`NAPHCON-A
`
`VISINE
`
`NAPHAZOUNE
`HYDROCHLORIDE;
`PHENIRAMINE MALEATE
`
`NAPHAZOUNE
`HYDROCHLORIDE;
`PHENIRAMINE MALEATE
`
`Showing 1 to 3 of 3 entries
`
`0.025%;0.3%
`
`SOLtmON/DROPS;OPHTHAL.MIC
`
`Over-the-counter
`
`No
`
`202795
`
`AKOf<N
`
`0.025%;0.3%
`
`SOLUTION/DROPS;OPHTHAL.MIC
`
`Over-the-counter
`
`Yes
`
`020226
`
`ALCOO
`
`0.025%;0.3%
`
`SOLUTION/DROPS;OPHTHALMIC
`
`Over-the- counter
`
`Yes
`
`020485
`
`JOHNSON AND
`JO HNSON
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020485
`
`1/1
`
`Eye Therapies Exhibit 2080, 1 of 1
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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