FDA Orange Book · active-ingredient family
Dexbrompheniramine maleate; pseudoephedrine sulfate
Dexbrompheniramine maleate; pseudoephedrine sulfate is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DRIXORAL · NDA 013483
2
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DRIXORALRLD×2 | SCHERING PLOUGH | NDA 013483 | — | Sep 13, 1982 | |
| DISOPHROL | SCHERING | NDA 012394 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE | AVANTHI INC | ANDA 078648 | — | Feb 27, 2013 | |
| DISOBROM | SANDOZ | ANDA 070770 | — | Sep 30, 1991 | |
| RESPORAL | PIONEER PHARMS | ANDA 089139 | — | Jun 16, 1988 | |
| BROMPHERIL | COPLEY PHARM | ANDA 089116 | — | Jan 22, 1987 |
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.
Dexbrompheniramine maleate; pseudoephedrine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
