FDA Orange Book · active-ingredient family
Atorvastatin calcium; ezetimibe
Atorvastatin calcium; ezetimibe is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LIPTRUZET · NDA 200153
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIPTRUZETRLD×4 | ORGANON | NDA 200153 | — | May 03, 2013 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LYPQOZET×4 | PHARMOBEDIENT | ANDA 206084 | — | Apr 26, 2017 |
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.
Atorvastatin calcium; ezetimibe — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
