FDA Orange Book · active-ingredient family
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CHILDREN'S ADVIL ALLERGY SINUS · NDA 021587
2
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHILDREN'S ADVIL ALLERGY SINUSRLD | HALEON US HOLDINGS | NDA 021587 | — | Feb 24, 2004 | |
| ADVIL ALLERGY SINUSRLD | HALEON US HOLDINGS | NDA 021441 | — | Dec 19, 2002 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7863287 | Feb 28, 2027 | in 8 mo | Product |
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
