Orange Book product · Generic (ANDA)
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
At a glance
Aug 22, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2019
6 yr 11 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 211830
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
- 2020NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213663 · GRANULES
- 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.
