Orange Book product · Generic (ANDA)
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE
At a glance
Apr 05, 2019
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 05, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOROLAC TROMETHAMINE
Strength
0.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 203410
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of KETOROLAC TROMETHAMINE
- 2010SPRIXBrand (NDA)
NDA 022382 · ZYLA
- 2009ACUVAILBrand (NDA)
NDA 022427 · ABBVIE
- 2003ACULAR LSBrand (NDA)
NDA 021528 · ABBVIE
- 1997ACULAR PRESERVATIVE FREEBrand (NDA)
NDA 020811 · ALLERGAN
- 1992ACULARBrand (NDA)
NDA 019700 · ABBVIE
- 1989TORADOLBrand (NDA)
NDA 019698 · ROCHE PALO
- 2024KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 218204 · CAPLIN
- 2023KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 217166 · ASPIRO
- 2023KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 217789 · CAPLIN
- 2023KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 216759 · BIONPHARMA
- 2022KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 214456 · ALEMBIC
- 2022KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 216407 · ATNAHS PHARMA US
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.
