Orange Book product · Generic (ANDA)
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Generic (ANDA)ANDA 212212TE ABRX TEVA PHARMS USA INC
At a glance
Apr 23, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 23, 2026
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
ANDA 212212
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
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.
