Application 018086

Type: NDA
Sponsor: VALEANT PHARMS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOPTIC	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.25% BASE	Yes	No
002	TIMOPTIC	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018086-001	TIMOPTIC	TIMOLOL MALEATE	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982
N018086-002	TIMOPTIC	TIMOLOL MALEATE	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018086-001	AT1
N018086-002	AT1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018086-001	TIMOPTIC	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018086-002	TIMOPTIC	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018086-001	TIMOPTIC	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018086-002	TIMOPTIC	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018086-001	AT1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018086-002	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-001	AT1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-002	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018086-001	AT1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018086-002	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-001	AT1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-002	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-001	AT1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-002	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-001	AT1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-002	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-001	AT1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-002	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-001	AT1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-002	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-001	AT1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-002	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018086-001	AT1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018086-002	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-001	AT1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-002	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-001	AT1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-002	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-001	AT1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-002	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018086-001	AT1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018086-002	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-001	AT1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-002	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018086-001	AT1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018086-002	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018086-001	AT1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018086-002	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018086-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018086-002	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018086-001	AT1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018086-002	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018086-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018086-002	AT1	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	9c14ca2d-80f3-48ef-b99a-beafaa728a24	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018086 application number: NDA018086 ndc (product): 82260-813 ndc (product): 82260-812
Timoptic	TIMOLOL MALEATE	Bausch & Lomb Incorporated	45ac65b3-19f7-4f33-aebf-cadd3daa4bf1	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018086 application number: NDA018086 ndc (product): 24208-812 ndc (product): 24208-813

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-812	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-812	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-812	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-812	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-812	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-812	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-813	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-813	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-813	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-813	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-813	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-813	Timoptic	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
68682-812	Timolol Maleate	Timolol Maleate	Oceanside Pharmaceuticals	NDA	Current
68682-812	Timolol Maleate	Timolol Maleate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-812	Timolol Maleate	Timolol Maleate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-813	Timolol Maleate	Timolol Maleate	Oceanside Pharmaceuticals	NDA	Current
68682-813	Timolol Maleate	Timolol Maleate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-813	Timolol Maleate	Timolol Maleate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
82260-812	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current
82260-812	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current
82260-813	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current
82260-813	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69352	SUPPL	2021-11-18
69341	SUPPL	2021-11-18
45018	SUPPL	2016-08-09
45016	SUPPL	2016-08-09
14912	SUPPL	2011-10-03
33434	SUPPL	2011-09-30
20107	SUPPL	2006-05-08
33433	SUPPL	2006-05-01
14911	SUPPL	2006-05-01
11160	SUPPL	2006-05-01
838	SUPPL	2006-05-01
837	SUPPL	2004-06-28
11159	SUPPL	2003-12-29
14910	SUPPL	2003-12-24
40777	SUPPL	2003-09-11
40776	SUPPL	2003-09-11
33432	SUPPL	2002-04-29
14032	SUPPL	2002-04-29
11158	SUPPL	2001-04-12