Orange Book product · Generic (ANDA)
BREYNA
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Generic (ANDA)ANDA 211699TE ABRX MYLAN
At a glance
Mar 15, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2022
4 yr 4 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 211699
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.
