FDA Orange Book · active-ingredient family
Fish oil; medium chain triglycerides; olive oil; soybean oil
Fish oil; medium chain triglycerides; olive oil; soybean oil is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SMOFLIPID 20% · NDA 207648
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · emulsion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SMOFLIPID 20%RLD×4 | FRESENIUS KABI USA | NDA 207648 | — | Jul 13, 2016 |
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.
Fish oil; medium chain triglycerides; olive oil; soybean oil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
