Orange Book product · Brand (NDA)
SMOFLIPID 20%
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
At a glance
Jul 13, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 13, 2016
10 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Strength
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)
Dosage form
EMULSION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 207648
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
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.
