Orange Book product · Generic (ANDA)
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
At a glance
Sep 24, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2020
5 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Strength
25MG;220MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 213663
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
- 2014ALEVE PMBrand (NDA)
NDA 205352 · BAYER HLTHCARE
- 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.
