Orange Book product · Brand (NDA)
FORADIL
FORMOTEROL FUMARATE
At a glance
Feb 16, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 16, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FORMOTEROL FUMARATE
Strength
0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 020831
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2007PERFOROMISTBrand (NDA)
NDA 022007 · VIATRIS SPECIALTY
- 2006FORADIL CERTIHALERBrand (NDA)
NDA 021592 · 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.
