FDA Orange Book · active-ingredient family
Diphenhydramine hydrochloride; naproxen sodium
Diphenhydramine hydrochloride; naproxen sodium is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALEVE PM · NDA 205352
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALEVE PMRLD | BAYER HLTHCARE | NDA 205352 | — | Jan 17, 2014 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | GRANULES | ANDA 213663 | — | Sep 24, 2020 | |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | COREPHARMA | ANDA 211830 | — | Aug 22, 2019 | |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | PERRIGO R AND D | ANDA 208499 | — | May 10, 2019 | |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | P AND L | ANDA 207597 | — | Jan 25, 2019 | |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | AMNEAL PHARMS CO | ANDA 209726 | — | Oct 23, 2018 |
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; naproxen sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
