Orange Book product · Brand (NDA)
PERFOROMIST
FORMOTEROL FUMARATE
At a glance
May 11, 2007
Approved
Brand (NDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 11, 2007
19 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
FORMOTEROL FUMARATE
Strength
0.02MG/2ML
Dosage form
SOLUTION
Route
INHALATION
TE code
AN
Application
NDA 022007
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.
- 2006FORADIL CERTIHALERBrand (NDA)
NDA 021592 · NOVARTIS
- 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.
