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Last Updated: October 7, 2024

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Harrow Eye MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y
Harrow Eye MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Thea Pharma ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Thea Pharma ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y
Catalyst Pharms AGAMREE vamorolone SUSPENSION;ORAL 215239-001 Oct 26, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
Catalyst Pharms AGAMREE vamorolone SUSPENSION;ORAL 215239-001 Oct 26, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use

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