Timolol Ophthalmic Solution

Brand(s)
Betimol, Istalol, Timoptic
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aton Pharma, Inc. (2013-09-13)
Oldest Current Product
1978-08-17
License(s)
NDA, ANDA
RxNORM
OPHTHALMIC SOLUTION\TIMOLOL
FDAOB
OPHTHALMIC\SOLUTION_DROPS\TIMOLOL
OPHTHALMIC\SOLUTION_DROPS\TIMOLOL MALEATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\TIMOLOL
OPHTHALMIC\SOLUTION/DROPS\TIMOLOL MALEATE
OPHTHALMIC\SOLUTION\TIMOLOL
OPHTHALMIC\SOLUTION\TIMOLOL MALEATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\TIMOLOL
OPHTHALMIC\SOLUTION/DROPS\TIMOLOL ANHYDROUS
OPHTHALMIC\SOLUTION/DROPS\TIMOLOL: TIMOLOL ANHYDROUS
OPHTHALMIC\SOLUTION\TIMOLOL
OPHTHALMIC\SOLUTION\TIMOLOL ANHYDROUS

product(s) by strength(s)

timolol 2.5 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001871498TimopticNDAValeant Pharmaceuticals North America Llc1986-11-05TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA019463c1293d51-b633-486c-8e13-fcf60063faeb
2250100812TimopticNDAAton Pharma, Inc.1978-08-17TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA01808698d81fc6-4482-45e5-8106-4dfd56f3433b
3764780001BetimolNDAOak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)2014-01-02TIMOLOLOPHTHALMICSOLUTION/DROPSNDA0204393d7acd55-33b1-4a24-99ae-01f87b0dca1f

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1165710140ANDAPack Pharmaceuticals Llc2009-02-16TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA077259acbba38a-dbd6-4d3b-8788-cadb7d5246ee
2242080330ANDABausch & Lomb Incorporated1997-03-25TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA0747785d58ead9-dec9-448b-9f46-07b48c1f636c
3555451000ANDAFdc Limited2014-12-15TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA0772592101d051-411e-466c-bba6-166a4615b17b
4605050597ANDAApotex Corp2011-07-15TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA07725945c57114-5f79-4d70-9423-7b87fb554971
5607580802ANDAPacific Pharma, Inc.1997-05-20TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA074746e16c33fd-aa86-49ad-a767-c79ade4a62c7
6613140226ANDASandoz Inc1996-01-15TIMOLOL MALEATEOPHTHALMICSOLUTIONANDA074261f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea
7649800513ANDARising Pharmaceuticals, Inc.2014-12-15TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA0772592ed21930-1e05-46de-8acd-cb6f4798a7fa
8678770228ANDAAscend Laboratories, Llc2011-03-092011-03-30TIMOLOL MALEATEOPHTHALMICSOLUTIONANDA07725985724f95-6fc9-4f0c-b69d-05a23b093e2b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780289ANDAAkorn2012-03-26TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA074465c9726422-f794-4d39-a437-17dcb8c0f3b5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683713ANDAPhysicians Total Care, Inc.1996-01-26TIMOLOL MALEATEOPHTHALMICSOLUTION613140226ANDA07426115732de7-64b9-4c42-897d-89ae1b330192
2617860341ANDARemedyrepack Inc.2015-06-16TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPS605050597ANDA077259e1044156-dfea-487d-8c6a-cad199dfce6c
3617860485ANDARemedyrepack Inc.2015-11-17TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPS607580802ANDA074746a746ff15-f8bc-44d1-85e3-4e44ddc1d1a1

timolol 5 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001871496TimopticNDAValeant Pharmaceuticals North America Llc1986-11-05TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA019463c1293d51-b633-486c-8e13-fcf60063faeb
2250100813TimopticNDAAton Pharma, Inc.1978-08-17TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA01808698d81fc6-4482-45e5-8106-4dfd56f3433b
3674250003IstalolNDAIsta Pharmaceuticals, Inc.2004-08-01TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA02151680fa20dc-b181-48be-83ce-d66a83753878
4686690525BetimolNDAVistakon Pharmaceuticals Llc2000-10-01TIMOLOLOPHTHALMICSOLUTIONNDA02043900f62dd1-dad2-4892-8a5d-21e5e54509ce

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1165710141ANDAPack Pharmaceuticals Llc2009-02-16TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA077259fe2832de-114f-49e1-8851-99d01c4361ff
2174780288ANDAAkorn2012-03-26TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA074466c9726422-f794-4d39-a437-17dcb8c0f3b5
3242080324ANDABausch & Lomb Incorporated1997-03-25TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA0747765d58ead9-dec9-448b-9f46-07b48c1f636c
4503830021ANDAHi-Tech Pharmacal Co., Inc.2002-09-10TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA07516363f36fa6-bd5a-49b2-b7bf-28ce0db3c6dc
5555451001ANDAFdc Limited2014-12-15TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA07725942887224-997c-4f08-8e2c-918de7195a6e
6605050598ANDAApotex Corp2011-07-15TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA07725945c57114-5f79-4d70-9423-7b87fb554971
7607580801ANDAPacific Pharma, Inc.1997-05-20TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPSANDA074747e16c33fd-aa86-49ad-a767-c79ade4a62c7
8613140227ANDASandoz Inc1996-01-15TIMOLOL MALEATEOPHTHALMICSOLUTIONANDA074262f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea
9678770229ANDAAscend Laboratories, Llc2011-03-09TIMOLOL MALEATEOPHTHALMICSOLUTIONANDA07725985724f95-6fc9-4f0c-b69d-05a23b093e2b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250482ANDARemedyrepack Inc.2013-12-03, 2014-01-09TIMOLOL MALEATEOPHTHALMICSOLUTION/DROPS607580801ANDA07474723b61c26-75fb-4d2a-9282-b7af27cbc6cb, 6d83efec-cd72-4093-a8d4-4dd5021e151e

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA074261TIMOLOL MALEATEALCON RESEARCH LTD1995-04-28ANDA074261_001
2ANDA074262TIMOLOL MALEATEALCON RESEARCH LTD1995-04-28ANDA074262_001
3ANDA074465TIMOLOL MALEATETrueAKORN INC1997-03-25ANDA074465_001
4ANDA074466TIMOLOL MALEATEAKORN INC1997-03-25ANDA074466_001
5ANDA074515TIMOLOL MALEATETrueAKORN INC1997-03-25ANDA074515_001
6ANDA074516TIMOLOL MALEATEAKORN INC1997-03-25ANDA074516_001
7ANDA074667TIMOLOL MALEATETrueE FOUGERA DIV ALTANA INC1997-03-25ANDA074667_001
8ANDA074668TIMOLOL MALEATETrueE FOUGERA DIV ALTANA INC1997-03-25ANDA074668_001
9ANDA074746TIMOLOL MALEATEPACIFIC PHARMA INC1997-03-25ANDA074746_001
10ANDA074747TIMOLOL MALEATEPACIFIC PHARMA1997-03-25ANDA074747_001
11ANDA074776TIMOLOL MALEATEBAUSCH AND LOMB INC1997-03-25ANDA074776_001
12ANDA074778TIMOLOL MALEATEBAUSCH AND LOMB PHARMACEUTICALS INC1997-03-25ANDA074778_001
13ANDA075163TIMOLOL MALEATEHI TECH PHARMACAL CO INC2002-09-10ANDA075163_001
14ANDA075411TIMOLOL MALEATETrueAPOTEX INC2000-09-08ANDA075411_001
15ANDA075412TIMOLOL MALEATETrueAPOTEX INC2000-09-08ANDA075412_001
16ANDA077259TIMOLOL MALEATEFDC LTD2008-04-30ANDA077259_001, ANDA077259_002
17ANDA078771TIMOLOL MALEATEWOCKHARDT LTD2009-09-28ANDA078771_001, ANDA078771_002
18ANDA204936TIMOLOL MALEATEAPOTEX INC2015-04-17ANDA204936_001
19NDA018086TIMOPTICATON PHARMA INCNDA018086_001, NDA018086_002
20NDA019463TIMOPTIC IN OCUDOSEATON PHARMA INC1986-11-05NDA019463_001, NDA019463_002
21NDA020439BETIMOLOAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC1995-03-31NDA020439_001, NDA020439_002
22NDA021516ISTALOLBAUSCH AND LOMB INC2004-06-04p6335335, SUBSTANCE
p6645963, SUBSTANCE
NDA021516_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074261_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1995-04-28TIMOLOL MALEATE
2ANDA074262_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT11995-04-28TIMOLOL MALEATE
3ANDA074465_001discontinuedTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalse1997-03-25TIMOLOL MALEATE
4ANDA074466_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT11997-03-25TIMOLOL MALEATE
5ANDA074515_001discontinuedTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalse1997-03-25TIMOLOL MALEATE
6ANDA074516_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT11997-03-25TIMOLOL MALEATE
7ANDA074667_001discontinuedTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalse1997-03-25TIMOLOL MALEATE
8ANDA074668_001discontinuedTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalse1997-03-25TIMOLOL MALEATE
9ANDA074746_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1997-03-25TIMOLOL MALEATE
10ANDA074747_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT11997-03-25TIMOLOL MALEATE
11ANDA074776_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT11997-03-25TIMOLOL MALEATE
12ANDA074778_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1997-03-25TIMOLOL MALEATE
13ANDA075163_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT12002-09-10TIMOLOL MALEATE
14ANDA075411_001discontinuedTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalse2000-09-08TIMOLOL MALEATE
15ANDA075412_001discontinuedTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalse2000-09-08TIMOLOL MALEATE
16ANDA077259_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2008-04-30TIMOLOL MALEATE
17ANDA077259_002RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT12008-04-30TIMOLOL MALEATE
18ANDA078771_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2009-09-28TIMOLOL MALEATE
19ANDA078771_002RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT12009-09-28TIMOLOL MALEATE
20ANDA204936_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSFalseAT22015-04-17TIMOLOL MALEATE
21NDA018086_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSTrueATTIMOPTIC
22NDA018086_002RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSTrueAT1TIMOPTIC
23NDA019463_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSTrue1986-11-05TIMOPTIC IN OCUDOSE
24NDA019463_002RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSTrue1986-11-05TIMOPTIC IN OCUDOSE
25NDA020439_001RXTIMOLOL (EQ 0.25% BASE)OPHTHALMICSOLUTION/DROPSTrue1995-03-31BETIMOL
26NDA020439_002RXTIMOLOL (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSTrue1995-03-31BETIMOL
27NDA021516_001RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION/DROPSTrueAT22004-06-04ISTALOL

patent(s)

#idexpiration dateapplication(s)
1p6335335 (view patent)2018-11-02NDA021516
2p6645963 (view patent)2018-11-16NDA021516

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100f62dd1-dad2-4892-8a5d-21e5e54509ce (view SPL)BETIMOL (timolol ophthalmic solution) 0.25%, 0.5%prescriptionHuman PrescriptionVistakon Pharmaceuticals Llc2010-03-183686690525, 686690522
215732de7-64b9-4c42-897d-89ae1b330192 (view SPL)Timolol Maleate Ophthalmic Solution USP STERILEprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-08-291548683713
315ca19c2-f28b-4703-aa23-5af265af9e8b (view SPL)TIMOPTIC 0.25% AND 0.5%(TIMOLOL MALEATE OPHTHALMIC SOLUTION)in OCUDOSE (DISPENSER)prescriptionHuman PrescriptionAton Pharma, Inc.MANUFACTURE2011-10-272250100814, 250100815
42101d051-411e-466c-bba6-166a4615b17b (view SPL)STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC SOLUTIONUSP 0.25% AND 0.5%prescriptionHuman PrescriptionFdc LimitedAnalysis, Manufacture2015-05-182555451000
523b61c26-75fb-4d2a-9282-b7af27cbc6cb (view SPL)TIMOLOL MALEATEophthalmic solution, USP 0.25% and 0.5%sterileprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-031521250482
6258bbc8d-00ee-45b0-ac35-6f16c4e8d45f (view SPL)These highlights do not include all the information needed to use ISTALOL (timolol maleate ophthalmic solution) 0.5% safely and effectively. See full prescribing information for ISTALOL. ISTALOL (timolol maleate ophthalmic solution) 0.5% Initial U.S. Approval: 1978STERILEprescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2013-06-0111242080004
72ed21930-1e05-46de-8acd-cb6f4798a7fa (view SPL)STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC SOLUTIONUSP 0.25% AND 0.5%prescriptionHuman PrescriptionRising Pharmaceuticals, Inc.Analysis, Manufacture2014-12-061649800513
83d7acd55-33b1-4a24-99ae-01f87b0dca1f (view SPL)prescriptionHuman PrescriptionOak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)2014-03-271764780001, 764780002
942887224-997c-4f08-8e2c-918de7195a6e (view SPL)STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC SOLUTIONUSP 0.25% AND 0.5%prescriptionHuman PrescriptionFdc LimitedAnalysis, Manufacture2015-05-182555451001
1045c57114-5f79-4d70-9423-7b87fb554971 (view SPL)STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5%prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2011-04-131605050597, 605050598
115d58ead9-dec9-448b-9f46-07b48c1f636c (view SPL)Timolol Maleate Ophthalmic Solution USPprescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2011-04-214242080324, 242080330
1263f36fa6-bd5a-49b2-b7bf-28ce0db3c6dc (view SPL)Timolol Maleate Ophthalmic Solution, USP 0.5%prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2013-09-254503830021
136d83efec-cd72-4093-a8d4-4dd5021e151e (view SPL)TIMOLOL MALEATEophthalmic solution, USP 0.25% and 0.5%sterileprescriptionHuman PrescriptionRemedyrepack Inc.2014-01-091521250482
1480fa20dc-b181-48be-83ce-d66a83753878 (view SPL)ISTALOL (timolol maleate ophthalmic solution) 0.5%SterileprescriptionHuman PrescriptionIsta Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2004-04-062674250003
1585724f95-6fc9-4f0c-b69d-05a23b093e2b (view SPL)prescriptionHuman PrescriptionAscend Laboratories, Llcmanufacture2013-10-154678770228, 678770229
1698d81fc6-4482-45e5-8106-4dfd56f3433b (view SPL)TIMOPTIC 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION)prescriptionHuman PrescriptionAton Pharma, Inc.MANUFACTURE2013-09-133250100812, 250100813
17a746ff15-f8bc-44d1-85e3-4e44ddc1d1a1 (view SPL)TIMOLOL MALEATEophthalmic solution, USP 0.25% and 0.5%sterileprescriptionHuman PrescriptionRemedyrepack Inc.2015-11-171617860485
18acbba38a-dbd6-4d3b-8788-cadb7d5246ee (view SPL)TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5%prescriptionHuman PrescriptionPack Pharmaceuticals Llcmanufacture2011-09-164165710140
19c1293d51-b633-486c-8e13-fcf60063faeb (view SPL)TIMOPTIC 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) in OCUDOSE (DISPENSER)prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-08-171001871496, 001871498
20c9726422-f794-4d39-a437-17dcb8c0f3b5 (view SPL)TIMOLOL MALEATEOPHTHALMIC SOLUTION, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-03-204174780288, 174780289
21e1044156-dfea-487d-8c6a-cad199dfce6c (view SPL)STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5%prescriptionHuman PrescriptionRemedyrepack Inc.2015-06-161617860341
22e16c33fd-aa86-49ad-a767-c79ade4a62c7 (view SPL)TIMOLOL MALEATEophthalmic solution, USP 0.25% and 0.5%sterileprescriptionHuman PrescriptionPacific Pharma, Inc.MANUFACTURE2015-06-098607580801, 607580802
23f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea (view SPL)Timolol Maleate Ophthalmic Solution USP STERILEprescriptionHuman PrescriptionSandoz Inc2012-12-193613140226, 613140227
24fe2832de-114f-49e1-8851-99d01c4361ff (view SPL)TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5%prescriptionHuman PrescriptionPack Pharmaceuticals Llcmanufacture2011-09-164165710141

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII