FDA Orange Book · active-ingredient family
Ibuprofen; phenylephrine hydrochloride
Ibuprofen; phenylephrine hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADVIL CONGESTION RELIEF · NDA 022565
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADVIL CONGESTION RELIEFRLD | HALEON US HOLDINGS | NDA 022565 | — | May 27, 2010 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | PERRIGO R AND D | ANDA 203200 | — | Jul 03, 2014 |
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.
Ibuprofen; phenylephrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
