Orange Book product · Brand (NDA)
CELEBREX
CELECOXIB
At a glance
Aug 29, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2002
24 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CELECOXIB
Strength
400MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020998
Product number
003
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.
- 2025VYSCOXABrand (NDA)
NDA 211759 · CARWIN PHARM ASSOC
- 2020ELYXYBBrand (NDA)
NDA 212157 · SCILEX PHARMS
- 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.
