Orange Book product · Brand (NDA)
DULERA
FORMOTEROL FUMARATE; MOMETASONE FUROATE
At a glance
Aug 12, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 12, 2019
6 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FORMOTEROL FUMARATE; MOMETASONE FUROATE
Strength
0.005MG/INH;0.05MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 022518
Product number
003
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.
