Orange Book product · Brand (NDA)
SINCALIDE
SINCALIDE
At a glance
Nov 22, 2022
Approved
Brand (NDA)
Application
AP
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2022
3 yr 8 mo ago
Today
Patent 11110063 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11110063 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11110063 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11318100 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11318100 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11318100 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11318100 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11737983 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Patent 11737983 expires
Listed drug product patent expiration.
Apr 20, 2038
in 12 yr
Pharmaceutical detail
Active ingredient
SINCALIDE
Strength
0.005MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 210850
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11110063 | Apr 20, 2038 | in 12 yr | ProductU-3481 |
| 11110063 | Apr 20, 2038 | in 12 yr | ProductU-3482 |
| 11110063 | Apr 20, 2038 | in 12 yr | ProductU-3483 |
| 11318100 | Apr 20, 2038 | in 12 yr | ProductU-3477 |
| 11318100 | Apr 20, 2038 | in 12 yr | ProductU-3478 |
| 11318100 | Apr 20, 2038 | in 12 yr | ProductU-3479 |
| 11318100 | Apr 20, 2038 | in 12 yr | ProductU-3480 |
| 11737983 | Apr 20, 2038 | in 12 yr | ProductU-3482 |
| 11737983 | Apr 20, 2038 | in 12 yr | ProductU-3689 |

