Orange Book product · Brand (NDA)
ALEVE PM
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
At a glance
Jan 17, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 17, 2014
12 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Strength
25MG;220MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 205352
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213663 · GRANULES
- 2019NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211830 · COREPHARMA
- 2019NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208499 · PERRIGO R AND D
- 2019NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207597 · P AND L
- 2018NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209726 · AMNEAL PHARMS CO
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.
