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Last Updated: March 28, 2024

Brompheniramine maleate - Generic Drug Details


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What are the generic drug sources for brompheniramine maleate and what is the scope of freedom to operate?

Brompheniramine maleate is the generic ingredient in eight branded drugs marketed by Alpharma Us Pharms, Kv Pharm, Pharm Assoc, Usl Pharma, Watson Labs, Wyeth Ayerst, Wyeth Cons, Barr, Ivax Sub Teva Pharms, Newtron Pharms, Nexgen Pharma Inc, Par Pharm, Pioneer Pharms, Upsher Smith Labs, Vitarine, Wockhardt, Wockhardt Bio Ag, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Rhodes Pharms, Taro, Wes Pharma Inc, Robins Ah, and Alza, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for brompheniramine maleate.

Recent Clinical Trials for brompheniramine maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ache Laboratorios Farmaceuticos S.A.Phase 3
Wyeth is now a wholly owned subsidiary of PfizerPhase 1

See all brompheniramine maleate clinical trials

Medical Subject Heading (MeSH) Categories for brompheniramine maleate

US Patents and Regulatory Information for brompheniramine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Assoc BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 202940-001 Jul 21, 2014 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 203997-001 Sep 30, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 207676-001 Dec 4, 2018 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wyeth Cons DIMETANE brompheniramine maleate TABLET;ORAL 010799-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt Bio Ag BROMFED-DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088811-001 Jun 7, 1985 AA RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs BROMPHENIRAMINE MALEATE brompheniramine maleate INJECTABLE;INJECTION 083820-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alpharma Us Pharms BROMANATE DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088722-001 Mar 7, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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