FDA Orange Book · active-ingredient family
Ibuprofen; pseudoephedrine hydrochloride
Ibuprofen; pseudoephedrine hydrochloride is approved as 5 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADVIL COLD AND SINUS · NDA 021374
5
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADVIL COLD AND SINUSRLD | HALEON US HOLDINGS | NDA 021374 | — | May 30, 2002 | |
| CHILDREN'S MOTRIN COLDRLD | KENVUE BRANDS | NDA 021128 | — | Aug 01, 2000 | |
| ADVIL COLD AND SINUSRLD | HALEON US HOLDINGS | NDA 019771 | — | Sep 19, 1989 | |
| CHILDREN'S ADVIL COLD | HALEON US HOLDINGS | NDA 021373 | — | Apr 18, 2002 | |
| SINE-AID IB | KENVUE BRANDS | NDA 019899 | — | Dec 31, 1992 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 213565 | — | Mar 10, 2023 | |
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 209235 | — | Dec 01, 2017 | |
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | STRIDES PHARMA | ANDA 077628 | — | Aug 14, 2006 | |
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | PERRIGO | ANDA 076478 | — | Nov 05, 2003 | |
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | CONTRACT PHARMACAL | ANDA 075588 | — | Apr 08, 2002 | |
| IBUPROHM COLD AND SINUS | OHM LABS | ANDA 074567 | — | Apr 17, 2001 |
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; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
