Orange Book product · Brand (NDA)
SPRIX
KETOROLAC TROMETHAMINE
At a glance
May 14, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 2010
16 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOROLAC TROMETHAMINE
Strength
15.75MG/SPRAY
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 022382
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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
- 2020KETOROLAC TROMETHAMINEGeneric (ANDA)
ANDA 205190 · EUGIA PHARMA
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.
