Orange Book product · Generic (ANDA)
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Generic (ANDA)ANDA 211360OTC AUROBINDO PHARMA
At a glance
Jun 01, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 01, 2022
4 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
220MG;120MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 211360
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
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.
