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Last Updated: July 7, 2020

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BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride is the generic ingredient in four branded drugs marketed by Alpharma Us Pharms, Wockhardt, Wockhardt Bio Ag, Acella, Lannett Co Inc, Mayne Pharma Inc, Paddock Llc, Taro, Vintage Pharms, and Robins Ah, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. Ten suppliers are listed for this compound.

Summary for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Pharmacology for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Us Pharms BROMANATE DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088722-001 Mar 7, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 207676-001 Dec 4, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag BROMFED-DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088811-001 Jun 7, 1985 AA RX No Yes   Start Trial   Start Trial   Start Trial
Taro BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 205112-001 Feb 27, 2017 AA RX No No   Start Trial   Start Trial   Start Trial
Paddock Llc BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 205292-001 Jul 15, 2014 AA RX No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 213125-001 Apr 17, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Johnson and Johnson
Express Scripts
AstraZeneca
Baxter

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