Orange Book product · Brand (NDA)
OPTISON
ALBUMIN HUMAN
At a glance
Dec 31, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1997
28 yr 11 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
Pharmaceutical detail
Active ingredient
ALBUMIN HUMAN
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020899
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)
May 09, 2028
in 1 yr 11 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.
