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Last Updated: November 24, 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
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No ⤷  Sign Up ⤷  Sign Up Y
Glaxosmithkline OJJAARA momelotinib dihydrochloride TABLET;ORAL 216873-001 Sep 15, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
Glaxosmithkline OJJAARA momelotinib dihydrochloride TABLET;ORAL 216873-002 Sep 15, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
Glaxosmithkline OJJAARA momelotinib dihydrochloride TABLET;ORAL 216873-003 Sep 15, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
>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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