FDA Orange Book · active-ingredient family
Brompheniramine maleate
Brompheniramine maleate: 2 brands, 16 generics; first approved Jan 25, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
16
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- WYETH CONSNDA 01079919833 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — 8MG TABLET, EXTENDED RELEASE ORAL Discontinued — 12MG TABLET, EXTENDED RELEASE ORAL Discontinued — - WYETH AYERSTNDA 011418—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- BROMPHENIRAMINE MALEATEPIONEER PHARMSANDA 0886041984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEUSL PHARMAANDA 0879641983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML ELIXIR ORAL Discontinued — - BROMPHENIRAMINE MALEATEALPHARMA US PHARMSANDA 086936—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML ELIXIR ORAL Discontinued — - BROMPHENIRAMINE MALEATEKV PHARMANDA 085466—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML ELIXIR ORAL Discontinued — - BROMPHENIRAMINE MALEATEPHARM ASSOCANDA 087517—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML ELIXIR ORAL Discontinued — - BROMPHENIRAMINE MALEATEWATSON LABSANDA 083821—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - BROMPHENIRAMINE MALEATEWATSON LABSANDA 083820—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - BROMPHENIRAMINE MALEATEBARRANDA 084468—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEIVAX SUB TEVA PHARMSANDA 084351—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATENEWTRON PHARMSANDA 086987—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATENEXGEN PHARMA INCANDA 086187—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEPAR PHARMANDA 087009—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEUPSHER SMITH LABSANDA 083215—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEVITARINEANDA 085850—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEWATSON LABSANDA 083123—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued — - BROMPHENIRAMINE MALEATEWATSON LABSANDA 085769—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 2 mo ago
Most recent approval
42 yr 8 mo ago
Approvals span 1983–1984 across 18 FDA applications.
Brand (NDA) 211%
Generic (ANDA) 1689%
Brompheniramine maleate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
