Orange Book product · Brand (NDA)
CLINOLIPID 20%
OLIVE OIL; SOYBEAN OIL
At a glance
Oct 03, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 03, 2013
12 yr 11 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 24, 2027
in 10 mo
Pharmaceutical detail
Active ingredient
OLIVE OIL; SOYBEAN OIL
Strength
16%(160GM/1000ML);4% (40GM/1000ML)
Dosage form
EMULSION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 204508
Product number
001
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.
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Apr 24, 2027
in 10 mo
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.
