timolol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| beta-adrenoreceptor antagonists | 4061 | 26839-75-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A beta-adrenergic antagonist that is similar in action to PROPRANOLOL; the levo-isomer is more active. Timolol has been proposed as an anti-hypertensive, anti-arrhythmic, anti-angina, and anti-glaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 20 | mg | O |
| 20 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 2.74 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 15 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 3.16 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 61 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.50 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 8.50 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.90 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.20 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 17, 1978 | FDA | ATON |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 604.28 | 46.68 | 114 | 964 | 3398 | 2353609 |
| Intraocular pressure increased | 428.02 | 46.68 | 75 | 1003 | 1434 | 2355573 |
| Ocular hyperaemia | 319.76 | 46.68 | 69 | 1009 | 3987 | 2353020 |
| Drug ineffective | 281.45 | 46.68 | 132 | 946 | 101492 | 2255515 |
| Eye pain | 274.32 | 46.68 | 63 | 1015 | 4828 | 2352179 |
| Product quality issue | 224.60 | 46.68 | 63 | 1015 | 10766 | 2346241 |
| Vision blurred | 197.18 | 46.68 | 61 | 1017 | 14607 | 2342400 |
| Eye pruritus | 154.41 | 46.68 | 35 | 1043 | 2496 | 2354511 |
| Bradycardia | 144.41 | 46.68 | 44 | 1034 | 9937 | 2347070 |
| Glaucoma | 144.30 | 46.68 | 32 | 1046 | 2063 | 2354944 |
| Visual acuity reduced | 101.18 | 46.68 | 29 | 1049 | 5269 | 2351738 |
| Dyspnoea | 93.41 | 46.68 | 59 | 1019 | 78674 | 2278333 |
| Hypersensitivity | 90.55 | 46.68 | 39 | 1039 | 23554 | 2333453 |
| Total lung capacity increased | 88.87 | 46.68 | 11 | 1067 | 9 | 2356998 |
| Dizziness | 82.29 | 46.68 | 49 | 1029 | 58616 | 2298391 |
| Eyelid margin crusting | 79.71 | 46.68 | 13 | 1065 | 153 | 2356854 |
| Product container issue | 79.32 | 46.68 | 16 | 1062 | 647 | 2356360 |
| Iris adhesions | 79.31 | 46.68 | 12 | 1066 | 83 | 2356924 |
| Incorrect dose administered | 72.43 | 46.68 | 26 | 1052 | 9669 | 2347338 |
| Eye discharge | 68.45 | 46.68 | 15 | 1063 | 908 | 2356099 |
| Dry eye | 68.12 | 46.68 | 20 | 1058 | 3936 | 2353071 |
| Hand deformity | 66.02 | 46.68 | 15 | 1063 | 1071 | 2355936 |
| No adverse event | 65.37 | 46.68 | 24 | 1054 | 9504 | 2347503 |
| Blood pressure systolic increased | 63.99 | 46.68 | 17 | 1061 | 2322 | 2354685 |
| Trabeculectomy | 63.38 | 46.68 | 8 | 1070 | 9 | 2356998 |
| Product dropper issue | 61.92 | 46.68 | 10 | 1068 | 110 | 2356897 |
| Eye swelling | 61.80 | 46.68 | 19 | 1059 | 4371 | 2352636 |
| Lacrimation increased | 60.78 | 46.68 | 17 | 1061 | 2813 | 2354194 |
| Sciatica | 60.78 | 46.68 | 16 | 1062 | 2109 | 2354898 |
| Visual impairment | 60.46 | 46.68 | 24 | 1054 | 11731 | 2345276 |
| Drug hypersensitivity | 60.19 | 46.68 | 37 | 1041 | 46606 | 2310401 |
| Frustration tolerance decreased | 58.78 | 46.68 | 13 | 1065 | 820 | 2356187 |
| Corneal oedema | 57.35 | 46.68 | 11 | 1067 | 341 | 2356666 |
| Respiration abnormal | 56.53 | 46.68 | 12 | 1066 | 624 | 2356383 |
| Cataract | 56.25 | 46.68 | 19 | 1059 | 5889 | 2351118 |
| Hypothermia | 55.85 | 46.68 | 15 | 1063 | 2133 | 2354874 |
| Intraocular pressure test abnormal | 53.29 | 46.68 | 8 | 1070 | 52 | 2356955 |
| Forced expiratory volume decreased | 52.55 | 46.68 | 11 | 1067 | 534 | 2356473 |
| Hypotony of eye | 52.17 | 46.68 | 8 | 1070 | 61 | 2356946 |
| Punctate keratitis | 52.03 | 46.68 | 9 | 1069 | 154 | 2356853 |
| Growth of eyelashes | 50.05 | 46.68 | 8 | 1070 | 82 | 2356925 |
| Foreign body sensation in eyes | 48.95 | 46.68 | 10 | 1068 | 430 | 2356577 |
| Keratopathy | 48.30 | 46.68 | 8 | 1070 | 104 | 2356903 |
| Vertigo | 47.67 | 46.68 | 19 | 1059 | 9365 | 2347642 |
| Hypotension | 47.64 | 46.68 | 28 | 1050 | 32408 | 2324599 |
| Obstructive airways disorder | 47.34 | 46.68 | 12 | 1066 | 1361 | 2355646 |
| Toxic anterior segment syndrome | 46.76 | 46.68 | 9 | 1069 | 284 | 2356723 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Intraocular pressure increased | 463.85 | 54.58 | 78 | 619 | 1103 | 1744981 |
| Eye irritation | 323.40 | 54.58 | 59 | 638 | 1344 | 1744740 |
| Bradycardia | 191.58 | 54.58 | 56 | 641 | 10478 | 1735606 |
| Eye pain | 171.77 | 54.58 | 38 | 659 | 2293 | 1743791 |
| Ocular hyperaemia | 166.05 | 54.58 | 36 | 661 | 1974 | 1744110 |
| Visual acuity reduced | 132.53 | 54.58 | 34 | 663 | 3854 | 1742230 |
| Corneal deposits | 122.88 | 54.58 | 18 | 679 | 90 | 1745994 |
| Drug ineffective | 121.39 | 54.58 | 66 | 631 | 63735 | 1682349 |
| Product quality issue | 104.14 | 54.58 | 31 | 666 | 6062 | 1740022 |
| Vision blurred | 98.32 | 54.58 | 32 | 665 | 8391 | 1737693 |
| Eye pruritus | 85.79 | 54.58 | 18 | 679 | 832 | 1745252 |
| Blindness | 78.49 | 54.58 | 21 | 676 | 2775 | 1743309 |
| Anterior chamber disorder | 71.77 | 54.58 | 10 | 687 | 32 | 1746052 |
| Glaucoma | 70.09 | 54.58 | 16 | 681 | 1095 | 1744989 |
| Corneal oedema | 69.85 | 54.58 | 13 | 684 | 320 | 1745764 |
| Product container issue | 69.58 | 54.58 | 13 | 684 | 327 | 1745757 |
| Lacrimation increased | 66.10 | 54.58 | 16 | 681 | 1412 | 1744672 |
| Intraocular pressure test abnormal | 63.86 | 54.58 | 9 | 688 | 32 | 1746052 |
| Hyphaema | 63.10 | 54.58 | 10 | 687 | 90 | 1745994 |
| Thunderclap headache | 57.11 | 54.58 | 7 | 690 | 4 | 1746080 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C07AA06 | CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS Beta blocking agents, non-selective |
| ATC | S01ED01 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIGLAUCOMA PREPARATIONS AND MIOTICS Beta blocking agents1) |
| ATC | C07BA06 | CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS AND THIAZIDES Beta blocking agents, non-selective, and thiazides |
| ATC | C07DA06 | CARDIOVASCULAR SYSTEM BETA BLOCKING AGENTS BETA BLOCKING AGENTS, THIAZIDES AND OTHER DIURETICS Beta blocking agents, non-selective, thiazides and other diuretics |
| ATC | S01ED51 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIGLAUCOMA PREPARATIONS AND MIOTICS Beta blocking agents1) |
| MeSH PA | D018663 | Adrenergic Agents |
| MeSH PA | D018674 | Adrenergic Antagonists |
| MeSH PA | D000319 | Adrenergic beta-Antagonists |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:38070 | anti-arrhythmia drug |
| CHEBI has role | CHEBI:35530 | beta-adrenergic antagonist |
| CHEBI has role | CHEBI:39456 | antiglaucoma drug |
| MeSH PA | D000889 | Anti-Arrhythmia Agents |
| MeSH PA | D000959 | Antihypertensive Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D018377 | Neurotransmitter Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Ocular hypertension | indication | 4210003 | DOID:9282 |
| Hypertensive disorder | indication | 38341003 | DOID:10763 |
| Open-angle glaucoma | indication | 84494001 | DOID:1067 |
| Myocardial Reinfarction Prevention | indication | ||
| Migraine Prevention | indication | ||
| Malignant glaucoma | off-label use | 10100008 | |
| Aphakic glaucoma | off-label use | 15374009 | |
| Secondary glaucoma | off-label use | 95717004 | |
| Angina pectoris | off-label use | 194828000 | |
| Angle-closure glaucoma | off-label use | 392291006 | DOID:13550 |
| Mitral valve prolapse | off-label use | 409712001 | |
| Anuria | contraindication | 2472002 | DOID:2983 |
| Bronchospasm | contraindication | 4386001 | |
| Hypercholesterolemia | contraindication | 13644009 | |
| Secondary angle-closure glaucoma | contraindication | 21571006 | |
| Complete atrioventricular block | contraindication | 27885002 | |
| Hypovolemia | contraindication | 28560003 | |
| Orthostatic hypotension | contraindication | 28651003 | |
| Acute cerebrovascular insufficiency | contraindication | 29322000 | |
| Dehydration | contraindication | 34095006 | |
| Hyperthyroidism | contraindication | 34486009 | DOID:7998 |
| Depressive disorder | contraindication | 35489007 | |
| Hyperuricemia | contraindication | 35885006 | DOID:1920 |
| Anaphylaxis | contraindication | 39579001 | |
| Hypokalemia | contraindication | 43339004 | |
| Sinus bradycardia | contraindication | 49710005 | |
| General anesthesia | contraindication | 50697003 | |
| Thromboangiitis obliterans | contraindication | 52403007 | DOID:12918 |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Sympathectomy | contraindication | 57071006 | |
| Acute nephropathy | contraindication | 58574008 | |
| Cerebrovascular disease | contraindication | 62914000 | DOID:6713 |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Hyperparathyroidism | contraindication | 66999008 | DOID:13543 |
| Hypochloremic alkalosis | contraindication | 70134007 | |
| Hepatic coma | contraindication | 72836002 | DOID:12550 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Pulmonary emphysema | contraindication | 87433001 | |
| Cardiogenic shock | contraindication | 89138009 | |
| Hyponatremia | contraindication | 89627008 | |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Myasthenia gravis | contraindication | 91637004 | DOID:437 |
| Acute disease of cardiovascular system | contraindication | 128487001 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Partial atrioventricular block | contraindication | 195039008 | |
| Decompensated cardiac failure | contraindication | 195111005 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Hypoglycemic disorder | contraindication | 237630007 | |
| Raynaud's phenomenon | contraindication | 266261006 | |
| Neonatal hyperbilirubinemia | contraindication | 281610001 | |
| Pregnancy, function | contraindication | 289908002 | |
| Severe chronic obstructive pulmonary disease | contraindication | 313299006 | |
| Right ventricular failure | contraindication | 367363000 | |
| Azotemia | contraindication | 445009001 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.15 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 7030149 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 7320976 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 7642258 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 8133890 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 8354409 | April 19, 2022 | REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH ELEVATED INTRAOCULAR PRESSURE OR GLAUCOMA |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 8748425 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 9474751 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 9770453 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION, WITH COMPARABLE EFFICACY, AND A REDUCTION IN SPECIFIED ADVERSE EVENTS, COMPARED TO BRIMONIDINE 0.2% TID |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 9907801 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION, WITH A REDUCTION IN SPECIFIED ADVERSE EVENTS, COMPARED TO BRIMONIDINE 0.2% TID |
| EQ 0.5% BASE | COMBIGAN | ALLERGAN | N021398 | Oct. 30, 2007 | RX | SOLUTION/DROPS | OPHTHALMIC | 9907802 | April 19, 2022 | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION, WITH COMPARABLE EFFICACY TO BRIMONIDINE 0.2% TID |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-1 adrenergic receptor | GPCR | ANTAGONIST | Ki | 9 | WOMBAT-PK | CHEMBL | |||
| Beta-2 adrenergic receptor | GPCR | ANTAGONIST | Ki | 9.70 | WOMBAT-PK | CHEMBL | |||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 5.81 | DRUG MATRIX | |||||
| Beta-3 adrenergic receptor | GPCR | Ki | 6.47 | DRUG MATRIX | |||||
| Beta-2 adrenergic receptor | GPCR | Kd | 9.78 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 6.21 | CHEMBL | |||||
| Beta-1 adrenergic receptor | GPCR | Kd | 9.44 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019949 | VUID |
| N0000148034 | NUI |
| C0040233 | UMLSCUI |
| D00378 | KEGG_DRUG |
| 85591001 | SNOMEDCT_US |
| 4019949 | VANDF |
| 10600 | RXNORM |
| 372880004 | SNOMEDCT_US |
| d00139 | MMSL |
| 004741 | NDDF |
| 817W3C6175 | UNII |
| 91524-16-2 | SECONDARY_CAS_RN |
| CHEMBL499 | ChEMBL_ID |
| DB00373 | DRUGBANK_ID |
| TIM | PDB_CHEM_ID |
| CHEBI:60787 | CHEBI |
| 33624 | PUBCHEM_CID |
| CHEMBL1200870 | ChEMBL_ID |
| D013999 | MESH_DESCRIPTOR_UI |
| 565 | IUPHAR_LIGAND_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| COMBIGAN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0023-9211 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | NDA | 17 sections |
| Timoptic in Ocudose | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-1496 | SOLUTION | 6.80 mg | OPHTHALMIC | NDA | 12 sections |
| Timoptic in Ocudose | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-1498 | SOLUTION | 3.40 mg | OPHTHALMIC | NDA | 12 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0055 | TABLET | 5 mg | ORAL | ANDA | 11 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0221 | TABLET | 10 mg | ORAL | ANDA | 11 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0715 | TABLET | 20 mg | ORAL | ANDA | 11 sections |
| Dorzolamide Hydrochloride-Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0527-1763 | SOLUTION | 5 mg | OPHTHALMIC | ANDA | 13 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13811-618 | TABLET | 5 mg | ORAL | ANDA | 11 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13811-619 | TABLET | 10 mg | ORAL | ANDA | 11 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13811-620 | TABLET | 20 mg | ORAL | ANDA | 11 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-288 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 12 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-289 | SOLUTION/ DROPS | 2.50 mg | OPHTHALMIC | ANDA | 12 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-365 | SOLUTION/ DROPS | 2.50 mg | OPHTHALMIC | ANDA | 11 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-366 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 11 sections |
| Dorzolamide HCl and Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 17478-514 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 18 sections |
| COSOPT PF | HUMAN PRESCRIPTION DRUG LABEL | 2 | 17478-604 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | NDA | 18 sections |
| COSOPT | HUMAN PRESCRIPTION DRUG LABEL | 2 | 17478-605 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | NDA | 17 sections |
| Istalol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-004 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | NDA | 17 sections |
| Dorzolamide Hydrochloride and Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 24208-486 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 17 sections |
| Timoptic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-812 | SOLUTION | 2.50 mg | OPHTHALMIC | NDA | 12 sections |
| Timoptic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-813 | SOLUTION | 5 mg | OPHTHALMIC | NDA | 12 sections |
| Timoptic-XE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-814 | SOLUTION | 2.50 mg | OPHTHALMIC | NDA | 13 sections |
| Timoptic-XE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-816 | SOLUTION | 5 mg | OPHTHALMIC | NDA | 13 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-818 | SOLUTION | 2.50 mg | OPHTHALMIC | NDA authorized generic | 13 sections |
| Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-819 | SOLUTION | 5 mg | OPHTHALMIC | NDA authorized generic | 13 sections |
| Timoptic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25010-814 | SOLUTION | 2.50 mg | OPHTHALMIC | NDA | 12 sections |
| Timoptic | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25010-815 | SOLUTION | 5 mg | OPHTHALMIC | NDA | 12 sections |
| Dorzolamide Hydrochloride and Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-1247 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 16 sections |
| TIMOLOL MALEATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-1852 | SOLUTION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 12 sections |
| Dorzolamide HCl and Timolol Maleate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-2867 | SOLUTION | 5 mg | OPHTHALMIC | ANDA | 18 sections |