FDA Orange Book · active-ingredient family
Halcinonide
Halcinonide is approved as 6 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HALOG · NDA 017556
6
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALOGRLD | SUN PHARM INDS INC | NDA 017556 | AB | Approved Prior to Jan 1, 1982 | |
| HALOGRLD | WESTWOOD SQUIBB | NDA 017818 | — | Approved Prior to Jan 1, 1982 | |
| HALOGRLD | BRISTOL MYERS SQUIBB | NDA 018125 | — | Approved Prior to Jan 1, 1982 | |
| HALOGRLD | SUN PHARM INDS INC | NDA 017824 | — | Approved Prior to Jan 1, 1982 | |
| HALOGRLD | SUN PHARM INDS INC | NDA 017823 | AT | Approved Prior to Jan 1, 1982 | |
| HALOG-E | SUN PHARM INDS INC | NDA 018234 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALCINONIDE | ENCUBE | ANDA 217671 | AT | May 29, 2024 | |
| HALCINONIDE | CHARTWELL RX | ANDA 214723 | AB | Sep 08, 2021 | |
| HALCINONIDE | MYLAN | ANDA 211027 | AB | Aug 12, 2019 |
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.
Halcinonide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
