Regulatory PathRegulatory requirements compared

Active substance

Ketorolac

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ACULAR LS 0.4% OPHTHALMIC SOLUTION0.4 %Ophthalmic solution · Ophthalmic use1 Dropper ContainerSAR 19.20NCE · PrescriptionAbbVie IncValid
ACUVAIL ophthalmic solution0.45 %Ophthalmic solution · Ophthalmic use30 Single Dose ContainerSAR 35.45NCE · PrescriptionAbbVie IncValid
KETOTHROM30 mg/mlSolution for injection · Intravenous use6 AmpouleSAR 35.20NCE · PrescriptionPT. Novell Pharmaceutical LaboratoriesValid
Ketorolac BOS30 mg/mlInjection · Intramuscular and intravenous use25 VialSAR 313.25NCE · PrescriptionBoston Oncology ArabiaValid
trolac10 mg/mlSolution for injection · Intramuscular and intravenous use5 AmpouleSAR 19.70Generic · PrescriptionPharma Pharmaceutical Industries (PPI)Valid
trolac30 mg/mlSolution for injection · Intramuscular and intravenous use5 AmpouleSAR 21.70Generic · PrescriptionPharma Pharmaceutical Industries (PPI)Valid
ACULAR 0.5% OPHTHALMIC SOLUTION0.5 %Ophthalmic solution · Ophthalmic use1 Dropper ContainerSAR 19.20NCE · PrescriptionALLERGAN PHARMACEUTICALS LTDWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); CYSTOID MACULAR EDEMA; NON-INFECTIOUS UVEITIS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ACULAR0.5%solution/drops · ophthalmicABBVIEPrescription9 Nov 1992
KETOROLAC TROMETHAMINE10MGtablet · oralTEVAPrescription16 May 1997
KETOROLAC TROMETHAMINE10MGtablet · oralMYLANPrescription16 May 1997
KETOROLAC TROMETHAMINE15MG/ML; 30MG/MLinjectable · injectionHOSPIRAPrescription5 Jun 1997
KETOROLAC TROMETHAMINE15MG/ML; 30MG/MLinjectable · injectionFRESENIUS KABI USAPrescription11 Jan 2002
ACULAR LS0.4%solution/drops · ophthalmicABBVIEPrescription30 May 2003
KETOROLAC TROMETHAMINE15MG/ML; 30MG/ML; 60MG/2MLinjectable · injectionHIKMA PHARMSPrescription21 Jul 2004
KETOROLAC TROMETHAMINE60MG/2MLinjectable · injectionAMPHASTAR PHARMPrescription21 Jul 2004
KETOROLAC TROMETHAMINE60MG/2MLinjectable · injectionGLAND PHARMA LTDPrescription27 Jul 2004
KETOROLAC TROMETHAMINE30MG/MLinjectable · injectionSANDOZPrescription6 Oct 2004
KETOROLAC TROMETHAMINE15MG/ML; 30MG/MLinjectable · injectionAPOTEXPrescription27 Mar 2007
ACUVAIL0.45%solution/drops · ophthalmicABBVIEPrescription22 Jul 2009
KETOROLAC TROMETHAMINE0.5%solution/drops · ophthalmicAPOTEXPrescription5 Nov 2009
KETOROLAC TROMETHAMINE0.5%solution/drops · ophthalmicSANDOZPrescription5 Nov 2009
SPRIX15.75MG/SPRAYspray, metered · nasalCOSETTEPrescription14 May 2010
KETOROLAC TROMETHAMINE15MG/ML; 30MG/MLinjectable · injectionSAGENT PHARMS INCPrescription27 Nov 2013
KETOROLAC TROMETHAMINE30MG/MLinjectable · injectionFRESENIUS KABI USAPrescription7 Oct 2015
KETOROLAC TROMETHAMINE15MG/ML; 30MG/MLinjectable · injectionGLANDPrescription1 Nov 2016
KETOROLAC TROMETHAMINE30MG/ML; 15MG/MLinjectable · injectionBAXTER HLTHCARE CORPPrescription15 Sep 2017
KETOROLAC TROMETHAMINE10MGtablet · oralCHARTWELL RXPrescription16 Aug 2018
KETOROLAC TROMETHAMINE0.5%solution/drops · ophthalmicMICRO LABS LTD INDIAPrescription5 Apr 2019
KETOROLAC TROMETHAMINE30MG/MLinjectable · injectionNEPHRONPrescription20 Aug 2020
KETOROLAC TROMETHAMINE10MGtablet · oralSENORES PHARMSPrescription23 Mar 2022
KETOROLAC TROMETHAMINE10MGtablet · oralHETERO LABS LTD IIIPrescription25 Aug 2022
KETOROLAC TROMETHAMINE10MGtablet · oralZYDUS LIFESCIENCESPrescription21 Oct 2022

43 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACULAR019683000.5 % / W/VSOLUTION · OPHTHALMICABBVIE CORPORATION
ACUVAIL023693620.45 % / W/VSOLUTION · OPHTHALMICABBVIE CORPORATION
APO-KETOROLAC0222908010 MGTABLET · ORALAPOTEX INC
JAMP KETOROLAC0251085510 MGTABLET · ORALJAMP PHARMA CORPORATION
KETOROLAC022458210.5 %SOLUTION · OPHTHALMICAA PHARMA INC
KETOROLAC TROMETHAMINE INJECTION, USP0224494730 MG / MLLIQUID · INTRAMUSCULARFRESENIUS KABI CANADA LTD
KETOROLAC TROMETHAMINE INJECTION, USP0244337630 MG / MLSOLUTION · INTRAMUSCULARJUNO PHARMA CANADA INC.
MAR-KETOROLAC0246512410 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-KETOROLAC0246145510 MGTABLET · ORALMINT PHARMACEUTICALS INC
TORADOL0216266010 MGTABLET · ORALAA PHARMA INC
TORADOL IM0216264410 MG / MLSOLUTION · INTRAMUSCULARATNAHS PHARMA UK LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACACULAR LS 0.4% OPHTH SOL$54.455per ML23 Sep 2026
US NADACKETOROLAC 0.4% OPHTH SOLUTION$12.67371per ML23 Sep 2026
US NADACKETOROLAC 0.5% OPHTH SOLUTION$1.45085per ML23 Sep 2026
US NADACKETOROLAC 0.5% OPHTH SOLUTION$1.33836per ML23 Sep 2026
US NADACKETOROLAC 10 MG TABLET$0.16448per EA23 Sep 2026
US NADACKETOROLAC 30 MG/ML VIAL$1.01747per ML23 Sep 2026
US NADACKETOROLAC 60 MG/2 ML VIAL$0.55237per ML23 Sep 2026
NHS Drug TariffKetorolac 0.5% eye drops£3.925 ml1 Oct 2026
NHS Drug TariffKetorolac 30mg/1ml solution for injection ampoules£5.365 ampoule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for ketorolac →

Combinations containing Ketorolac

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.