Orange Book product · Brand (NDA)
NAPROXEN SODIUM
NAPROXEN SODIUM
At a glance
Feb 17, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2006
20 yr 8 mo ago
Patent 10022344 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 10022344 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 10028925 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 10028925 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 11090280 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 11090280 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 9693978 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Patent 9693979 expires
Listed drug product patent expiration.
Mar 03, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
NAPROXEN SODIUM
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021920
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1996NAPRELANBrand (NDA)
NDA 020353 · TWI PHARMS
- 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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10022344 | Mar 03, 2026 | 4 mo ago | ProductU-1731 |
| 10022344 | Mar 03, 2026 | 4 mo ago | ProductU-1732 |
| 10028925 | Mar 03, 2026 | 4 mo ago | ProductU-1731 |
| 10028925 | Mar 03, 2026 | 4 mo ago | ProductU-1732 |
| 11090280 | Mar 03, 2026 | 4 mo ago | ProductU-1731 |
| 11090280 | Mar 03, 2026 | 4 mo ago | ProductU-1732 |
| 9693978 | Mar 03, 2026 | 4 mo ago | Product |
| 9693979 | Mar 03, 2026 | 4 mo ago | Product |
