FDA Orange Book · active-ingredient family
Albumin human
Albumin human is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OPTISON · NDA 020899
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OPTISONRLD | GE HEALTHCARE | NDA 020899 | — | Dec 31, 1997 |
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.
Albumin human — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
