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Last Updated: September 25, 2020

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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, Lannett Co Inc, Mayne Pharma Inc, Paddock Llc, Taro, Vintage Pharms, Wes Pharma Inc, Robins Ah, and Alza, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for brompheniramine maleate.

Summary 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 PfizerN/A

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
Watson Labs BROMPHENIRAMINE MALEATE brompheniramine maleate INJECTABLE;INJECTION 083820-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Vitarine BROMPHENIRAMINE MALEATE brompheniramine maleate TABLET;ORAL 085850-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Newtron Pharms BROMPHENIRAMINE MALEATE brompheniramine maleate TABLET;ORAL 086987-001 Approved Prior to Jan 1, 1982 DISCN 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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Merck
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