Orange Book product · Brand (NDA)
NAPRELAN
NAPROXEN SODIUM
At a glance
Jan 05, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 05, 1996
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPROXEN SODIUM
Strength
EQ 375MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 020353
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.
- 2006NAPROXEN SODIUMBrand (NDA)
NDA 021920 · BIONPHARMA
- 1994ALEVEBrand (NDA)
NDA 020204 · BAYER
- —ANAPROXBrand (NDA)
NDA 018164 · ATNAHS PHARMA US
- 2023NAPROXEN SODIUMGeneric (ANDA)
ANDA 214463 · PATHEON SOFTGELS
- 2022NAPROXEN SODIUMGeneric (ANDA)
ANDA 211065 · HETERO LABS LTD V
- 2022NAPROXEN SODIUMGeneric (ANDA)
ANDA 215472 · ONESOURCE SPECIALTY
- 2019NAPROXEN SODIUMGeneric (ANDA)
ANDA 212199 · SCIEGEN PHARMS
- 2019NAPROXEN SODIUMGeneric (ANDA)
ANDA 212033 · YICHANG HUMANWELL
- 2019NAPROXEN SODIUMGeneric (ANDA)
ANDA 202807 · CATALENT
- 2018NAPROXEN SODIUMGeneric (ANDA)
ANDA 207612 · NOVELGENIX THERAPS
- 2018NAPROXEN SODIUMGeneric (ANDA)
ANDA 208363 · PURACAP PHARM LLC
- 2017NAPROXEN SODIUMGeneric (ANDA)
ANDA 204872 · LNK INTL 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.
