Orange Book product · Brand (NDA)
NAPROSYN
NAPROXEN
At a glance
Mar 23, 1987
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 1987
39 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPROXEN
Strength
25MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 018965
Product number
001
Marketing status
RX
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
- —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
- 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.
