Application 019463

Type: NDA
Sponsor: VALEANT PHARMS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.25% BASE	Yes	Yes
002	TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	Yes	Yes

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
N019463-001	TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05
N019463-002	TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019463-001	AT3
N019463-002	AT3

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	N019463-001	AT3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019463-002	AT3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-001	AT3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-002	AT3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019463-001	AT3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019463-002	AT3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-001	AT3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-002	AT3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-001	AT3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-002	AT3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-001	AT3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-002	AT3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-001	AT3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-002	AT3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-001	AT3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-002	AT3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-001	AT3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-002	AT3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019463-001	AT3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019463-002	AT3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-001	AT3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-002	AT3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-001	AT3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-002	AT3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-001	AT3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-002	AT3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019463-001	AT3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019463-002	AT3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-001	AT3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-002	AT3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019463-001	AT3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019463-002	AT3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019463-001	AT3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019463-002	AT3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019463-001	AT3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019463-002	AT3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019463-002	AT3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019463-002	AT3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019463-002	AT3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019463-002	AT3	1	`8869cabd3fbd…`

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.	036dc753-1698-4c69-9bcf-752c7061203c	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019463 application number: NDA019463 ndc (product): 82260-496
Timoptic in Ocudose	TIMOLOL MALEATE	Bausch & Lomb Incorporated	d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf	2022-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019463 application number: NDA019463 ndc (product): 24208-499 ndc (product): 24208-498

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-1496	Timoptic in Ocudose	Timolol Maleate	Bausch Health Americas Inc.	NDA	Current
0187-1496	Timoptic in Ocudose	Timolol Maleate	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-1496	Timoptic in Ocudose	Timolol Maleate	Bausch Health US LLC	NDA	Current
0187-1496	Timoptic in Ocudose	Timolol Maleate	Bausch Health US LLC	NDA	Current
0187-1496	Timoptic in Ocudose	Timolol Maleate	Bausch Health US LLC	NDA	Current
0187-1498	Timoptic in Ocudose	Timolol Maleate	Bausch Health Americas Inc.	NDA	Current
0187-1498	Timoptic in Ocudose	Timolol Maleate	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-1498	Timoptic in Ocudose	Timolol Maleate	Bausch Health US LLC	NDA	Current
0187-1498	Timoptic in Ocudose	Timolol Maleate	Bausch Health US LLC	NDA	Current
0187-1498	Timoptic in Ocudose	Timolol Maleate	Bausch Health US LLC	NDA	Current
24208-496	Timolol Maleate	Timolol Maleate	BAUSCH & LOMB INCORPORATED	NDA AUTHORIZED GENERIC	Current
24208-498	Timoptic in Ocudose	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
24208-499	Timoptic in Ocudose	Timolol Maleate	Bausch & Lomb Incorporated	NDA	Current
25010-814	Timoptic	Timolol Maleate	Aton Pharma, Inc.	NDA	Current
25010-815	Timoptic	Timolol Maleate	Aton Pharma, Inc.	NDA	Current
82260-496	Timolol Maleate	Timolol Maleate	Bausch & Lomb Americas Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47975	SUPPL	2017-04-12
47893	SUPPL	2017-04-07
17412	SUPPL	2011-10-03
33758	SUPPL	2011-09-30
1335	SUPPL	2006-06-08
33757	SUPPL	2006-06-06
20248	SUPPL	2006-05-08
33756	SUPPL	2003-12-29
1334	SUPPL	2003-12-24
20247	SUPPL	2003-09-11
33755	SUPPL	2003-04-15