Orange Book product · Generic (ANDA)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
At a glance
Oct 11, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 11, 2023
2 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Strength
EQ 20MG BASE;375MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 217738
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- 2010VIMOVOBrand (NDA)
NDA 022511 · HORIZON
- 2022NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 213699 · AJANTA PHARMA LTD
- 2022NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204470 · ACTAVIS LABS FL INC
- 2021NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204920 · PHARMOBEDIENT
- 2020NAPROXEN AND ESOMEPRAZOLE MAGNESIUMGeneric (ANDA)
ANDA 204206 · DR REDDYS
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.
