Orange Book product · Brand (NDA)
SYMBICORT
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
At a glance
Jul 21, 2006
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 21, 2006
20 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Strength
0.08MG/INH;0.0045MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
AB
Application
NDA 021929
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.
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.
