FDA Orange Book · active-ingredient family
Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride
Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIMETANE-DX · NDA 019279
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIMETANE-DXRLD | ROBINS AH | NDA 019279 | — | Aug 24, 1984 |
Generic (ANDA) products (13)
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; dextromethorphan hydrobromide; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
