FDA Orange Book · active-ingredient family
Sincalide
Sincalide is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SINCALIDE · NDA 210850
2
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SINCALIDERLD | MAIA PHARMS INC | NDA 210850 | AP | Nov 22, 2022 | |
| KINEVACRLD | BRACCO | NDA 017697 | AP | Approved Prior to Jan 1, 1982 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11737983 | Apr 20, 2038 | in 12 yr | ProductU-3482 |
| 11318100 | Apr 20, 2038 | in 12 yr | ProductU-3477 |
| 11110063 | Apr 20, 2038 | in 12 yr | ProductU-3481 |
Sincalide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
