FDA Orange Book · active-ingredient family
Diphenhydramine hydrochloride; ibuprofen
Diphenhydramine hydrochloride; ibuprofen is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADVIL PM · NDA 021393
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADVIL PMRLD | HALEON US HOLDINGS | NDA 021393 | — | Dec 21, 2005 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 210676 | — | Feb 14, 2019 | |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | ONESOURCE SPECIALTY | ANDA 200888 | — | Mar 05, 2012 | |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | BIONPHARMA | ANDA 090397 | — | Nov 22, 2010 |
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.
Diphenhydramine hydrochloride; ibuprofen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
