Orange Book product · Brand (NDA)
ROSZET
EZETIMIBE; ROSUVASTATIN CALCIUM
Brand (NDA)NDA 213072DISCN ALTHERA PHARMS
At a glance
Mar 23, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2021
5 yr 4 mo ago
Today
Patent 10376470 expires
Listed drug product patent expiration.
May 01, 2033
in 7 yr
Patent 9763885 expires
Listed drug product patent expiration.
May 01, 2033
in 7 yr
Pharmaceutical detail
Active ingredient
EZETIMIBE; ROSUVASTATIN CALCIUM
Strength
10MG;EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213072
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10376470 | May 01, 2033 | in 7 yr | ProductU-3095 |
| 9763885 | May 01, 2033 | in 7 yr | ProductU-3095 |
