Orange Book product · Brand (NDA)
NAPROSYN
NAPROXEN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NAPROXEN
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 017581
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1994EC-NAPROSYNBrand (NDA)
NDA 020067 · ATNAHS PHARMA US
- 1987NAPROSYNBrand (NDA)
NDA 018965 · 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
- 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.
