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Last Updated: November 2, 2024

Bromodiphenhydramine hydrochloride - Generic Drug Details


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What are the generic drug sources for bromodiphenhydramine hydrochloride and what is the scope of patent protection?

Bromodiphenhydramine hydrochloride is the generic ingredient in four branded drugs marketed by Parke Davis, Forest Labs, Alpharma Us Pharms, and Wockhardt, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for bromodiphenhydramine hydrochloride.

Summary for bromodiphenhydramine hydrochloride

US Patents and Regulatory Information for bromodiphenhydramine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs AMBENYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 009319-006 Jan 10, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alpharma Us Pharms BROMANYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088343-001 Aug 15, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Parke Davis AMBODRYL bromodiphenhydramine hydrochloride CAPSULE;ORAL 007984-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Wockhardt BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088626-001 Oct 12, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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