drug · Product Intelligence

Diphenhydramine
Pipeline Intelligence

Diphenhydramine: 2 indexed trials, 2 sponsors; 0 linked Orange Book patents and 20 FDA-linked events where matched.

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2Indexed trials
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2Sponsors
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0Orange Book patent links
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20FDA-linked events

Development evidence

NCT01669967London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · pain_neuropathyNA
NCT05501678Stanford University · autismPHASE2

FDA / patent evidence

Orange Book match found; no listed patent relation was retained for this product match.

Regulatory context

FDA_APPROVALNAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE · 2020-09-24
FDA_APPROVALNAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE · 2019-08-22
FDA_APPROVALALEVE PM · 2014-01-17
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1987-01-02
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1987-01-02
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1985-05-31
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1985-05-15
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1985-05-15
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1983-01-27
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE · 1983-01-27
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE ·
FDA_APPROVALDIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE ·

FDA Orange Book coverage is U.S.-specific and is not a substitute for worldwide patent or regulatory review.