Orange Book product · Generic (ANDA)
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
At a glance
Oct 23, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 23, 2018
7 yr 9 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 209726
Product number
001
Marketing status
DISCN
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 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
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.
