ketorolac Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibufenac derivatives 1529 74103-06-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ketorolac
  • ketorolac tromethamine
  • ketorolac trometamol
  • trometamol ketorolac
  • (+/-)-Ketorolac
  • keromin
A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity.
  • Molecular weight: 255.27
  • Formula: C15H13NO3
  • CLOGP: 1.62
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 59.30
  • ALOGS: -2.70
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 200 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 58 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 9.79 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.11 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.35 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 30, 1989 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 423.26 12.36 461 15953 264781 53067871
Spinal epidural haematoma 125.77 12.36 33 16381 848 53331804
Punctate keratitis 82.76 12.36 22 16392 595 53332057
Skin papilloma 79.84 12.36 35 16379 4416 53328236
Corneal epithelium defect 74.16 12.36 18 16396 334 53332318
Corneal oedema 65.80 12.36 24 16390 1873 53330779
Tendon disorder 60.16 12.36 31 16383 5604 53327048
Eye pain 58.57 12.36 59 16355 30666 53301986
Injury 58.16 12.36 75 16339 50896 53281756
Anterior chamber cell 54.87 12.36 16 16398 612 53332040
Eye irritation 53.89 12.36 45 16369 18404 53314248
Renal infarct 48.72 12.36 18 16396 1456 53331196
Purpura fulminans 46.15 12.36 9 16405 55 53332597
Extradural haematoma 45.94 12.36 18 16396 1710 53330942
Aspirin-exacerbated respiratory disease 45.00 12.36 15 16399 895 53331757
Retinal pigment epitheliopathy 44.44 12.36 11 16403 222 53332430
Migraine 43.52 12.36 84 16330 80333 53252319
Quadriplegia 41.08 12.36 17 16397 1861 53330791
Ulcerative keratitis 39.74 12.36 18 16396 2451 53330201
Uterine perforation 37.14 12.36 25 16389 7394 53325258
Meniscus injury 37.14 12.36 24 16390 6631 53326021
Anaphylactic reaction 36.67 12.36 65 16349 58261 53274391
Endophthalmitis 36.18 12.36 19 16395 3568 53329084
Emotional distress 35.99 12.36 47 16367 32270 53300382
Urinoma 35.72 12.36 7 16407 44 53332608
Treatment failure 35.33 12.36 103 16311 128300 53204352
Corneal disorder 35.20 12.36 15 16399 1766 53330886
Sleep disorder 33.71 12.36 63 16351 58807 53273845
Concussion 33.67 12.36 24 16390 7780 53324872
Musculoskeletal disorder 32.24 12.36 33 16381 17466 53315186
Vision blurred 32.02 12.36 77 16337 85527 53247125
Visual acuity reduced 30.32 12.36 36 16378 22449 53310203
Ocular hyperaemia 29.57 12.36 35 16379 21756 53310896
Intraocular pressure increased 28.24 12.36 20 16394 6418 53326234
Respiratory tract infection viral 24.67 12.36 12 16402 1919 53330733
Myelomalacia 24.46 12.36 5 16409 40 53332612
Systemic lupus erythematosus 23.40 12.36 5 16409 125409 53207243
Asymptomatic bacteriuria 23.28 12.36 7 16407 298 53332354
Kounis syndrome 22.48 12.36 10 16404 1305 53331347
Toxic anterior segment syndrome 22.45 12.36 12 16402 2336 53330316
Renal ischaemia 22.24 12.36 8 16406 600 53332052
Photophobia 21.87 12.36 26 16388 16232 53316420
Spinal cord compression 21.62 12.36 14 16400 3880 53328772
Fibrosis 21.30 12.36 14 16400 3978 53328674
Dystonia 21.21 12.36 23 16391 12998 53319654
Foreign body sensation in eyes 21.14 12.36 11 16403 2028 53330624
Septic arthritis staphylococcal 20.77 12.36 7 16407 432 53332220
Sinusitis 20.31 12.36 104 16310 168460 53164192
Corneal thinning 19.50 12.36 5 16409 117 53332535
Post-traumatic stress disorder 19.08 12.36 14 16400 4744 53327908
Corneal abrasion 18.80 12.36 8 16406 938 53331714
Abdominal compartment syndrome 18.21 12.36 7 16407 632 53332020
Intervertebral discitis 17.82 12.36 11 16403 2806 53329846
Diarrhoea 17.40 12.36 117 16297 625429 52707223
Sphincter of Oddi dysfunction 17.39 12.36 6 16408 398 53332254
Condition aggravated 17.33 12.36 153 16261 296981 53035671
Hypersensitivity 17.00 12.36 117 16297 210548 53122104
Persistent corneal epithelial defect 16.87 12.36 3 16411 10 53332642
Embedded device 16.41 12.36 11 16403 3230 53329422
Torsade de pointes 16.19 12.36 20 16394 12985 53319667
Corneal perforation 15.98 12.36 6 16408 508 53332144
Paraplegia 15.90 12.36 10 16404 2637 53330015
Alopecia 15.89 12.36 30 16384 234553 53098099
Angioedema 15.88 12.36 38 16376 42038 53290614
Renal papillary necrosis 15.83 12.36 5 16409 251 53332401
Labelled drug-drug interaction medication error 15.61 12.36 18 16396 10881 53321771
Anxiety 15.14 12.36 108 16306 196596 53136056
Fascial infection 15.03 12.36 3 16411 21 53332631
Death 14.92 12.36 58 16356 357174 52975478
Embolia cutis medicamentosa 14.86 12.36 5 16409 307 53332345
Sensory loss 14.73 12.36 15 16399 7890 53324762
Corneal scar 14.71 12.36 4 16410 118 53332534
Hand deformity 14.62 12.36 4 16410 84845 53247807
Corneal dystrophy 14.41 12.36 5 16409 337 53332315
Atrophy 14.34 12.36 8 16406 1694 53330958
Opisthotonus 14.17 12.36 5 16409 354 53332298
Allodynia 13.98 12.36 6 16408 719 53331933
Corneal opacity 13.87 12.36 6 16408 733 53331919
Synovitis 13.83 12.36 8 16406 107885 53224767
Cataract 13.81 12.36 40 16374 49580 53283072
Nephrolithiasis 13.67 12.36 33 16381 36714 53295938
Laryngeal dyspnoea 13.38 12.36 4 16410 167 53332485
Internal injury 13.36 12.36 5 16409 419 53332233
Atrial fibrillation 13.32 12.36 9 16405 111643 53221009
Respiratory depression 13.29 12.36 18 16396 12788 53319864
Pupils unequal 12.95 12.36 7 16407 1392 53331260
Post procedural haemorrhage 12.85 12.36 14 16400 7954 53324698
Ileus 12.55 12.36 19 16395 14936 53317716
Tubulointerstitial nephritis 12.50 12.36 20 16394 16484 53316168
Hypopyon 12.42 12.36 6 16408 945 53331707
Colitis ischaemic 12.39 12.36 16 16398 10858 53321794

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Victim of child abuse 103.29 16.28 26 7515 757 32505228
Drug hypersensitivity 87.49 16.28 96 7445 73304 32432681
Respiratory depression 81.80 16.28 46 7495 13165 32492820
Treatment failure 72.21 16.28 65 7476 39098 32466887
Drug dependence 62.02 16.28 48 7493 23436 32482549
Anaphylactic reaction 57.42 16.28 51 7490 30121 32475864
Product prescribing error 55.80 16.28 42 7499 19675 32486310
Ulcerative keratitis 52.98 16.28 18 7523 1518 32504467
Nephrolithiasis 47.65 16.28 44 7497 27310 32478675
Sedation 47.03 16.28 37 7504 18489 32487496
Nightmare 46.29 16.28 32 7509 13134 32492851
Aspirin-exacerbated respiratory disease 45.32 16.28 12 7529 428 32505557
Epidural lipomatosis 44.97 16.28 13 7528 644 32505341
Child abuse 42.81 16.28 11 7530 348 32505637
Cataract 38.48 16.28 37 7504 24146 32481839
Corneal oedema 34.96 16.28 13 7528 1425 32504560
Juvenile idiopathic arthritis 34.28 16.28 13 7528 1505 32504480
Burning feet syndrome 33.35 16.28 7 7534 88 32505897
Asthma-chronic obstructive pulmonary disease overlap syndrome 27.74 16.28 10 7531 1004 32504981
Corneal thinning 24.78 16.28 6 7535 148 32505837
Cardiomyopathy 24.52 16.28 24 7517 15989 32489996
Bronchial hyperreactivity 23.43 16.28 10 7531 1572 32504413
Angioedema 23.34 16.28 35 7506 36254 32469731
Anterior chamber cell 23.19 16.28 7 7534 403 32505582
Eye pain 22.87 16.28 21 7520 12927 32493058
Hyperhidrosis 22.00 16.28 50 7491 71118 32434867
Urticaria 21.99 16.28 45 7496 59569 32446416
Superficial injury of eye 21.85 16.28 4 7537 23 32505962
Pulmonary function test abnormal 20.78 16.28 10 7531 2076 32503909
Periorbital swelling 20.72 16.28 6 7535 299 32505686
Intentional product misuse 20.71 16.28 33 7508 36018 32469967
Death 20.44 16.28 36 7505 382481 32123504
Drug abuse 20.12 16.28 52 7489 80191 32425794
Anaesthetic complication neurological 20.04 16.28 6 7535 336 32505649
Corneal epithelium defect 19.54 16.28 6 7535 366 32505619
Punctate keratitis 19.38 16.28 6 7535 376 32505609
Mixed liver injury 18.77 16.28 10 7531 2570 32503415
Blood chromogranin A increased 18.33 16.28 5 7536 200 32505785
Neuromuscular block prolonged 18.33 16.28 6 7535 451 32505534
Eye disorder 17.36 16.28 15 7526 8525 32497460
Carcinoid crisis 17.23 16.28 5 7536 251 32505734
Corneal opacity 16.88 16.28 6 7535 578 32505407
Corneal abrasion 16.77 16.28 5 7536 276 32505709
Bone neoplasm 16.46 16.28 5 7536 294 32505691

Pharmacologic Action:

SourceCodeDescription
ATC M01AB15 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC S01BC05 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC S01FB51 SENSORY ORGANS
OPHTHALMOLOGICALS
MYDRIATICS AND CYCLOPLEGICS
Sympathomimetics excl. antiglaucoma preparations
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drugs
CHEBI has role CHEBI:50629 cyclooxygenase-2 inhibitor
CHEBI has role CHEBI:50630 cyclooxygenase-1 inhibitor
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
FDA EPC N0000175939 Cyclooxygenase Inhibitor
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Severe pain indication 76948002
Allergic conjunctivitis indication 473460002 DOID:11204
Acute postoperative pain indication 107401000119105
Postoperative Ocular Pain indication
Post-Op Ocular Inflammation indication
Post-Op Photophobia indication
Renal colic off-label use 7093002
Peptic ulcer contraindication 13200003 DOID:750
Disorder of cornea contraindication 15250008 DOID:10124
Acute gastric ulcer with perforation contraindication 19850005
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Hypovolemia contraindication 28560003
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Tear film insufficiency contraindication 46152009
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Corneal erosion contraindication 50792001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Rheumatoid arthritis contraindication 69896004 DOID:7148
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Hemophilia contraindication 90935002
Corneal degeneration contraindication 111521006 DOID:1237
Perioperative care contraindication 133897009
Asthma contraindication 195967001 DOID:2841
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004
Pregnancy, function contraindication 289908002
Cardiovascular event risk contraindication 395112001
Gastric ulcer contraindication 397825006 DOID:10808
Breastfeeding (mother) contraindication 413712001
Smokes tobacco daily contraindication 449868002
Preoperative Pain Management contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.47 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.3% BASE;EQ 1% BASE OMIDRIA RAYNER SURGICAL N205388 May 30, 2014 RX SOLUTION IRRIGATION 8173707 July 30, 2023 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
EQ 0.3% BASE;EQ 1% BASE OMIDRIA RAYNER SURGICAL N205388 May 30, 2014 RX SOLUTION IRRIGATION 9278101 July 30, 2023 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8207215 May 28, 2024 A METHOD OF CONTROLLING POSTOPERATIVE OCULAR PAIN AND BURNING/STINGING IN A PATIENT
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8377982 May 28, 2024 A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING/STINGING FOLLOWING CORNEAL SURGERY
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8541463 May 28, 2024 A METHOD OF TREATING OR REDUCING OCULAR PAIN AND BURNING/STINGING
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8906950 May 28, 2024 A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8946281 May 28, 2024 A METHOD OF TREATING OCULAR PAIN
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 9216167 May 28, 2024 A METHOD OF TREATING OCULAR PAIN AND/OR ENHANCING OCULAR COMFORT
0.4% ACULAR LS ALLERGAN N021528 May 30, 2003 RX SOLUTION/DROPS OPHTHALMIC 8008338 May 24, 2027 A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 6.90 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 9.72 WOMBAT-PK CHEMBL
Serine/threonine-protein kinase PAK 1 Kinase IC50 4.44 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 4.94 CHEMBL
Aldose reductase Enzyme IC50 5.21 DRUG MATRIX
Prostaglandin-H2 D-isomerase Enzyme IC50 6.64 CHEMBL

External reference:

IDSource
4028637 VUID
N0000178380 NUI
D00813 KEGG_DRUG
74103-07-4 SECONDARY_CAS_RN
4019510 VANDF
4028637 VANDF
C0073631 UMLSCUI
CHEBI:6129 CHEBI
KTR PDB_CHEM_ID
CHEMBL469 ChEMBL_ID
CHEMBL1201124 ChEMBL_ID
DB00465 DRUGBANK_ID
D020910 MESH_DESCRIPTOR_UI
5558 INN_ID
3826 PUBCHEM_CID
6661 IUPHAR_LIGAND_ID
YZI5105V0L UNII
28200 RXNORM
30341 MMSL
39892 MMSL
4947 MMSL
9780 MMSL
d00273 MMSL
003539 NDDF
004812 NDDF
108512006 SNOMEDCT_US
108513001 SNOMEDCT_US
372501008 SNOMEDCT_US
D020911 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Acular HUMAN PRESCRIPTION DRUG LABEL 1 0023-2181 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 23 sections
ACUVAIL HUMAN PRESCRIPTION DRUG LABEL 1 0023-3507 SOLUTION/ DROPS 4.50 mg OPHTHALMIC NDA 23 sections
ACULAR LS HUMAN PRESCRIPTION DRUG LABEL 1 0023-9277 SOLUTION/ DROPS 4 mg OPHTHALMIC NDA 22 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0314 TABLET, FILM COATED 10 mg ORAL ANDA 27 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0338-0069 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 27 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0338-0072 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 27 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0338-0076 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 27 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-1134 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9883 INJECTION, SOLUTION 30 mg INTRAVENOUS ANDA 15 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9884 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 14 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9952 INJECTION, SOLUTION 15 mg INTRAVENOUS ANDA 14 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3793 INJECTION, SOLUTION 15 mg INTRAMUSCULAR ANDA 15 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3795 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 15 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3796 INJECTION, SOLUTION 60 mg INTRAMUSCULAR ANDA 15 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0487-6232 INJECTION 30 mg INTRAMUSCULAR ANDA 16 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6041 INJECTION 15 mg INTRAMUSCULAR ANDA 17 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6042 INJECTION 30 mg INTRAMUSCULAR ANDA 17 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6043 INJECTION 30 mg INTRAMUSCULAR ANDA 17 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 10544-222 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 12634-809 TABLET 10 mg ORAL ANDA 13 sections
ACULAR HUMAN PRESCRIPTION DRUG LABEL 1 16590-002 SOLUTION/ DROPS 5 mg OPHTHALMIC NDA 20 sections
KETOROLAC HUMAN PRESCRIPTION DRUG LABEL 1 16590-138 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
KETOROLAC TROMETHAMINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-376 SOLUTION 5 mg OPHTHALMIC ANDA 18 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 17478-207 SOLUTION/ DROPS 4.50 mg OPHTHALMIC ANDA 24 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 17478-208 SOLUTION 4 mg OPHTHALMIC ANDA 22 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 17478-209 SOLUTION 5 mg OPHTHALMIC ANDA 25 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-432 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
ACULAR HUMAN PRESCRIPTION DRUG LABEL 1 21695-463 SOLUTION 5 mg OPHTHALMIC NDA 10 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-588 INJECTION, SOLUTION 30 mg INTRAMUSCULAR ANDA 23 sections
Ketorolac Tromethamine HUMAN PRESCRIPTION DRUG LABEL 1 21695-624 SOLUTION 4 mg OPHTHALMIC ANDA 22 sections