Orange Book product · Brand (NDA)
BROMDAY
BROMFENAC SODIUM
At a glance
Oct 16, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2010
15 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BROMFENAC SODIUM
Strength
EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 021664
Product number
002
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.
- 2016BROMSITEBrand (NDA)
NDA 206911 · SUN PHARM
- 2013PROLENSABrand (NDA)
NDA 203168 · BAUSCH AND LOMB
- 2024BROMFENAC SODIUMGeneric (ANDA)
ANDA 210962 · AMNEAL
- 2024BROMFENAC SODIUMGeneric (ANDA)
ANDA 214340 · ALEMBIC
- 2024BROMFENAC SODIUMGeneric (ANDA)
ANDA 207334 · APOTEX
- 2024BROMFENAC SODIUMGeneric (ANDA)
ANDA 211239 · LUPIN
- 2023BROMFENAC SODIUMGeneric (ANDA)
ANDA 206027 · LUPIN
- 2023BROMFENAC SODIUMGeneric (ANDA)
ANDA 202903 · LUPIN
- 2022BROMFENAC SODIUMGeneric (ANDA)
ANDA 204813 · EUGIA PHARMA
- 2020BROMFENAC SODIUMGeneric (ANDA)
ANDA 211029 · GLAND
- 2019BROMFENAC SODIUMGeneric (ANDA)
ANDA 210560 · ALEMBIC
- 2019BROMFENAC SODIUMGeneric (ANDA)
ANDA 203368 · RISING
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.
