Application 077259

Type: ANDA
Sponsor: FDC LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.25% BASE	No	No
002	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	No	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
A077259-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2008-04-30
A077259-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2008-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077259-001	AT1
A077259-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`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	A077259-001	AT1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077259-002	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-001	AT1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-002	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077259-001	AT1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077259-002	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-001	AT1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-002	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-001	AT1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-002	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-001	AT1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-002	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-001	AT1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-002	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-001	AT1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-002	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-001	AT1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-002	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077259-001	AT1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077259-002	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-001	AT1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-002	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-001	AT1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-002	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-001	AT1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-002	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077259-001	AT1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077259-002	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-001	AT1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-002	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077259-001	AT1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077259-002	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077259-001	AT1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077259-002	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077259-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077259-002	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077259-001	AT1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077259-002	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077259-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077259-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIMOLOL MALEATE	TIMOLOL MALEATE	Rising Pharma Holdings, Inc.	2ed21930-1e05-46de-8acd-cb6f4798a7fa	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077259 application number: ANDA077259 ndc (product): 64980-513 ndc (product): 64980-514

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-121	TIMOLOL MALEATE	timolol maleate	Medsource Pharmaceuticals	ANDA	Current
50090-1852	TIMOLOL MALEATE	timolol maleate	A-S Medication Solutions	ANDA	Current
50090-5091	TIMOLOL MALEATE	timolol maleate	A-S Medication Solutions	ANDA	Current
55545-1000	TIMOLOL MALEATE	timolol maleate	FDC Limited	ANDA	Current
55545-1001	TIMOLOL MALEATE	timolol maleate	FDC Limited	ANDA	Current
64980-513	TIMOLOL MALEATE	timolol maleate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-513	TIMOLOL MALEATE	timolol maleate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-513	TIMOLOL MALEATE	timolol maleate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-514	TIMOLOL MALEATE	timolol maleate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-514	TIMOLOL MALEATE	timolol maleate	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-514	TIMOLOL MALEATE	timolol maleate	Rising Pharmaceuticals, Inc.	ANDA	Current
67877-229	Timolol Maleate	Timolol Maleate	Ascend Laboratories, LLC	ANDA	Current
68071-1558	TIMOLOL MALEATE	timolol maleate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2354	TIMOLOL MALEATE	timolol maleate	REMEDYREPACK INC.	ANDA	Current
76519-1163	TIMOLOL MALEATE	TIMOLOL MALEATE	H.J. Harkins Company, Inc.	ANDA	Current