FDA Orange Book · active-ingredient family
Ezetimibe; rosuvastatin calcium
Ezetimibe; rosuvastatin calcium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ROSZET · NDA 213072
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROSZETRLD×4 | ALTHERA PHARMS | NDA 213072 | — | Mar 23, 2021 |
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 |
Ezetimibe; rosuvastatin calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
