Orange Book product · Brand (NDA)
FORADIL CERTIHALER
FORMOTEROL FUMARATE
At a glance
Dec 15, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2006
19 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
FORMOTEROL FUMARATE
Strength
0.0085MG/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 021592
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2007PERFOROMISTBrand (NDA)
NDA 022007 · VIATRIS SPECIALTY
- 2001FORADILBrand (NDA)
NDA 020831 · NOVARTIS
- 2025FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 218308 · DEVA HOLDING AS
- 2025FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 215907 · DR REDDYS
- 2024FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 216426 · LEXENPHARM
- 2024FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 218304 · MICRO LABS
- 2023FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 215883 · MANKIND PHARMA
- 2022FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 215621 · WILSHIRE PHARMS INC
- 2022FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 216486 · RITEDOSE CORP
- 2022FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 215053 · LUPIN
- 2021FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 215078 · ALEMBIC
- 2021FORMOTEROL FUMARATEGeneric (ANDA)
ANDA 091141 · TEVA PHARMS USA INC
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.

