FDA Orange Book · active-ingredient family
Oxtriphylline
Oxtriphylline is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CHOLEDYL · NDA 009268
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, syrup, tablet, delayed release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHOLEDYL×4 | PARKE DAVIS | NDA 009268 | — | Nov 27, 1984 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXTRIPHYLLINE | MORTON GROVE | ANDA 088243 | — | Dec 05, 1983 | |
| OXTRIPHYLLINE PEDIATRIC | MORTON GROVE | ANDA 088242 | — | Dec 05, 1983 | |
| OXTRIPHYLLINE | WATSON LABS | ANDA 087866 | — | Aug 25, 1983 | |
| OXTRIPHYLLINE | WATSON LABS | ANDA 087835 | — | Aug 25, 1983 | |
| CHOLEDYL SA | WARNER CHILCOTT LLC | ANDA 087863 | — | May 24, 1983 | |
| CHOLEDYL SA | WARNER CHILCOTT LLC | ANDA 086742 | — | Approved Prior to Jan 1, 1982 |
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.
Oxtriphylline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
