Orange Book product · Brand (NDA)
COXANTO
OXAPROZIN
At a glance
Oct 20, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
OXAPROZIN
Strength
300MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 217927
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.
- 1992DAYPROBrand (NDA)
NDA 018841 · PFIZER
- 2017OXAPROZINGeneric (ANDA)
ANDA 208633 · AMNEAL PHARMS CO
- 2004OXAPROZINGeneric (ANDA)
ANDA 075987 · CHARTWELL
- 2002OXAPROZINGeneric (ANDA)
ANDA 075849 · TEVA
- 2002OXAPROZINGeneric (ANDA)
ANDA 075846 · IVAX SUB TEVA PHARMS
- 2002OXAPROZINGeneric (ANDA)
ANDA 075844 · SUN PHARM INDS INC
- 2001OXAPROZINGeneric (ANDA)
ANDA 075843 · ACTAVIS ELIZABETH
- 2001OXAPROZINGeneric (ANDA)
ANDA 075851 · PHARMOBEDIENT
- 2001OXAPROZINGeneric (ANDA)
ANDA 075850 · SANDOZ
- 2001OXAPROZINGeneric (ANDA)
ANDA 075842 · AARXION ANDA HLDING
- 2001OXAPROZINGeneric (ANDA)
ANDA 075847 · MYLAN PHARMS INC
- 2001OXAPROZINGeneric (ANDA)
ANDA 075848 · WATSON LABS
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.
