Orange Book product · Generic (ANDA)
NAPROXEN
NAPROXEN
At a glance
May 26, 1999
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 1999
27 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPROXEN
Strength
375MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 075337
Product number
001
Marketing status
DISCN
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
- 2023NAPROXENGeneric (ANDA)
ANDA 216908 · TP ANDA HOLDINGS
- 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
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.
