Orange Book product · Generic (ANDA)
BROMFENAC SODIUM
BROMFENAC SODIUM
At a glance
Aug 15, 2023
Approved
Generic (ANDA)
Application
AT2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 15, 2023
2 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BROMFENAC SODIUM
Strength
EQ 0.09% ACID
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT2
Application
ANDA 202903
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BROMFENAC SODIUM
- 2016BROMSITEBrand (NDA)
NDA 206911 · SUN PHARM
- 2013PROLENSABrand (NDA)
NDA 203168 · BAUSCH AND LOMB
- 2010BROMDAYBrand (NDA)
NDA 021664 · BAUSCH AND LOMB INC
- 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
- 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.
