FDA Orange Book · active-ingredient family
Diphenhydramine citrate; ibuprofen
Diphenhydramine citrate; ibuprofen is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADVIL PM · NDA 021394
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADVIL PMRLD | HALEON US HOLDINGS | NDA 021394 | — | Dec 21, 2005 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | PLD ACQUISITIONS LLC | ANDA 211404 | — | Apr 11, 2024 | |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | AUROBINDO PHARMA | ANDA 216204 | — | May 31, 2022 | |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DR REDDYS LABS LTD | ANDA 090619 | — | Jul 08, 2009 | |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | PERRIGO R AND D | ANDA 079113 | — | Dec 22, 2008 |
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 citrate; ibuprofen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
