Orange Book product · Brand (NDA)
OZEMPIC
SEMAGLUTIDE
Brand (NDA)NDA 209637RX NOVO
At a glance
May 05, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 05, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
SEMAGLUTIDE
Strength
0.25MG/0.5ML (0.25MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 209637
Product number
005
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.
