Orange Book product · Generic (ANDA)
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE
At a glance
Apr 26, 1999
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 1999
27 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOROLAC TROMETHAMINE
Strength
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 075222
Product number
001
Marketing status
DISCN
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.
