Orange Book product · Generic (ANDA)
NAPROXEN
NAPROXEN
At a glance
May 31, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 2023
3 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPROXEN
Strength
375MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 216908
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NAPROXEN
- 1994EC-NAPROSYNBrand (NDA)
NDA 020067 · ATNAHS PHARMA US
- 1987NAPROSYNBrand (NDA)
NDA 018965 · ATNAHS PHARMA US
- —NAPROSYNBrand (NDA)
NDA 017581 · ATNAHS PHARMA US
- 2025NAPROXENGeneric (ANDA)
ANDA 216504 · AUROBINDO PHARMA
- 2024NAPROXENGeneric (ANDA)
ANDA 218497 · NOVITIUM PHARMA
- 2022NAPROXENGeneric (ANDA)
ANDA 215776 · HETERO LABS LTD III
- 2021NAPROXENGeneric (ANDA)
ANDA 211910 · NOVITIUM PHARMA
- 2020NAPROXENGeneric (ANDA)
ANDA 212705 · AMNEAL
- 2020NAPROXENGeneric (ANDA)
ANDA 212517 · SCIEGEN PHARMS
- 2011NAPROXENGeneric (ANDA)
ANDA 200429 · AUROBINDO PHARMA
- 2011NAPROXENGeneric (ANDA)
ANDA 091432 · NUVO PHARMS INC
- 2011NAPROXENGeneric (ANDA)
ANDA 091305 · INVAGEN PHARMS
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.
