Orange Book product · Brand (NDA)
VYSCOXA
CELECOXIB
At a glance
Jul 29, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
CELECOXIB
Strength
10MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 211759
Product number
001
Marketing status
RX
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.
- 2020ELYXYBBrand (NDA)
NDA 212157 · SCILEX PHARMS
- 2006CELEBREXBrand (NDA)
NDA 020998 · UPJOHN
- 2025CELECOXIBGeneric (ANDA)
ANDA 205938 · ZYDUS PHARMS
- 2025CELECOXIBGeneric (ANDA)
ANDA 213127 · STRIDES PHARMA
- 2023CELECOXIBGeneric (ANDA)
ANDA 212564 · YABAO PHARM
- 2021CELECOXIBGeneric (ANDA)
ANDA 213301 · UNICHEM
- 2020CELECOXIBGeneric (ANDA)
ANDA 212925 · PANGEA
- 2020CELECOXIBGeneric (ANDA)
ANDA 205129 · SCIEGEN PHARMS
- 2020CELECOXIBGeneric (ANDA)
ANDA 213598 · NANJING
- 2020CELECOXIBGeneric (ANDA)
ANDA 211412 · YILING
- 2020CELECOXIBGeneric (ANDA)
ANDA 207872 · TIANJIN TIANYAO
- 2019CELECOXIBGeneric (ANDA)
ANDA 210628 · UMEDICA
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.
