FDA Orange Book · active-ingredient family
Sevoflurane
Sevoflurane is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ULTANE · NDA 020478
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · liquid
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ULTANERLD | ABBVIE | NDA 020478 | AN | Jun 07, 1995 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SEVOFLURANE | SHANDONG | ANDA 214382 | AN | Aug 18, 2023 | |
| SEVOFLURANE | SHANGHAI HENGRUI | ANDA 203793 | AN | Nov 03, 2015 | |
| SEVOFLURANE | HALOCARBON PRODS | ANDA 078650 | AN | Nov 19, 2007 | |
| SOJOURN | PIRAMAL CRITICAL | ANDA 077867 | AN | May 02, 2007 | |
| SEVOFLURANE | BAXTER HLTHCARE | ANDA 075895 | AN | Jul 02, 2002 |
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.
Sevoflurane — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
