FDA Orange Book · active-ingredient family
Brompheniramine maleate
Brompheniramine maleate is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIMETANE · NDA 010799
2
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · elixir, injectable, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIMETANE×3 | WYETH CONS | NDA 010799 | — | Jun 10, 1983 | |
| DIMETANE-TEN | WYETH AYERST | NDA 011418 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE | PIONEER PHARMS | ANDA 088604 | — | Jul 13, 1984 | |
| BROMPHENIRAMINE MALEATE | USL PHARMA | ANDA 087964 | — | Jan 25, 1983 | |
| BROMPHENIRAMINE MALEATE | ALPHARMA US PHARMS | ANDA 086936 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | KV PHARM | ANDA 085466 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | PHARM ASSOC | ANDA 087517 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | WATSON LABS | ANDA 083821 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | WATSON LABS | ANDA 083820 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | BARR | ANDA 084468 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | IVAX SUB TEVA PHARMS | ANDA 084351 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | NEWTRON PHARMS | ANDA 086987 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | NEXGEN PHARMA INC | ANDA 086187 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | PAR PHARM | ANDA 087009 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | UPSHER SMITH LABS | ANDA 083215 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | VITARINE | ANDA 085850 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | WATSON LABS | ANDA 083123 | — | Approved Prior to Jan 1, 1982 | |
| BROMPHENIRAMINE MALEATE | WATSON LABS | ANDA 085769 | — | Approved Prior to Jan 1, 1982 |
Listed patents
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.
Brompheniramine maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
