FDA Orange Book · active-ingredient family
Oxaprozin
Oxaprozin is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COXANTO · NDA 217927
2
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COXANTORLD | SOLUBIOMIX | NDA 217927 | — | Oct 20, 2023 | |
| DAYPRORLD | PFIZER | NDA 018841 | AB | Oct 29, 1992 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXAPROZIN | AMNEAL PHARMS CO | ANDA 208633 | AB | May 04, 2017 | |
| OXAPROZIN | CHARTWELL | ANDA 075987 | AB | Sep 02, 2004 | |
| OXAPROZIN | TEVA | ANDA 075849 | — | Jul 03, 2002 | |
| OXAPROZIN | IVAX SUB TEVA PHARMS | ANDA 075846 | — | May 13, 2002 | |
| OXAPROZIN | SUN PHARM INDS INC | ANDA 075844 | — | Jan 03, 2002 | |
| OXAPROZIN | ACTAVIS ELIZABETH | ANDA 075843 | — | Oct 03, 2001 | |
| OXAPROZIN | PHARMOBEDIENT | ANDA 075851 | — | Aug 17, 2001 | |
| OXAPROZIN | SANDOZ | ANDA 075850 | — | Apr 27, 2001 | |
| OXAPROZIN | AARXION ANDA HLDING | ANDA 075842 | — | Apr 12, 2001 | |
| OXAPROZIN | MYLAN PHARMS INC | ANDA 075847 | — | Feb 28, 2001 | |
| OXAPROZIN | WATSON LABS | ANDA 075848 | — | Feb 09, 2001 | |
| OXAPROZIN | DR REDDYS LABS LTD | ANDA 075855 | AB | Jan 31, 2001 | |
| OXAPROZIN | PANGEA | ANDA 075845 | AB | Jan 31, 2001 |
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.
Oxaprozin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
