FDA Orange Book · active-ingredient family
Flurandrenolide
Flurandrenolide is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CORDRAN SP · NDA 012806
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion, ointment, tape
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CORDRAN SPRLD×4 | INA PHARMS | NDA 012806 | — | Approved Prior to Jan 1, 1982 | |
| CORDRANRLD | INA PHARMS | NDA 013790 | — | Approved Prior to Jan 1, 1982 | |
| CORDRANRLD | ALMIRALL | NDA 016455 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLURANDRENOLIDE | TELIGENT | ANDA 207851 | — | Dec 30, 2016 | |
| FLURANDRENOLIDE | CHARTWELL RX | ANDA 205343 | — | Dec 22, 2016 | |
| FLURANDRENOLIDE | PADAGIS ISRAEL | ANDA 207133 | — | Aug 30, 2016 | |
| FLURANDRENOLIDE | CHARTWELL RX | ANDA 205342 | — | Apr 13, 2016 | |
| FLURANDRENOLIDE | ALPHARMA US PHARMS | ANDA 087203 | — | Apr 29, 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.
Flurandrenolide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
