Application 212291

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212291-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3		2020-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212291-001	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.

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	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212291-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2020-09-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212291-001	AT3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212291-001	AT3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212291-001	AT3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212291-001	AT3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212291-001	AT3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212291-001	AT3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212291-001	AT3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212291-001	AT3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212291-001	AT3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212291-001	AT3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212291-001	AT3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212291-001	AT3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212291-001	AT3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212291-001	AT3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212291-001	AT3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212291-001	AT3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212291-001	AT3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212291-001	AT3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212291-001	AT3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212291-001	AT3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212291-001	AT3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212291-001	AT3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212291-001	AT3	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212291-001	AT3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212291-001	AT3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212291-001	AT3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212291-001	AT3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212291-001	AT3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212291-001	AT3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212291-001	AT3	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212291-001	AT3	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212291-001	AT3	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212291-001	AT3	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212291-001	AT3	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212291-001	AT3	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212291-001	AT3	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212291-001	AT3	1	`a50c72e98297…`

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 2 of 2 · 32 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.	0bc40b2c-65eb-4095-87e6-4752d5b19a3a	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
TIMOLOL MALEATE	TIMOLOL MALEATE	A-S Medication Solutions	1ffd9ed1-8ab4-4036-bbc6-dcf58e659248	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: TIMOLOL MALEATE generic name: TIMOLOL MALEATE
Timolol GFS	TIMOLOL MALEATE	Sandoz Inc	72b0d0ec-832a-4c25-b845-2537ab506354	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL MALEATE
TIMOLOL MALEATE	TIMOLOL MALEATE	Aurobindo Pharma Limited	e6c74f66-ee84-4bcc-b1da-b8e6ff240dd2	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: TIMOLOL MALEATE generic name: TIMOLOL MALEATE
TIMOLOL MALEATE	TIMOLOL MALEATE	Pacific Pharma, Inc.	e16c33fd-aa86-49ad-a767-c79ade4a62c7	2024-03-14	Warnings, Adverse reactions	Name fallback brand name: TIMOLOL MALEATE generic name: TIMOLOL MALEATE
timolol maleate	TIMOLOL MALEATE	First Nation Group, LLC	140e1bfc-b75e-40d1-856c-242be4d9c8cc	2024-03-07	Warnings, Adverse reactions	Name fallback brand name: timolol maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Ingenus Pharmaceuticals, LLC	4c4318b3-9865-4172-a7bd-9e68913eca1e	2023-10-25	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
timolol maleate	TIMOLOL MALEATE	Lifestar Pharma LLC	545b7bee-8d5d-4206-b973-8de3c14d6dfe	2023-07-03	Warnings, Adverse reactions	Name fallback brand name: timolol maleate generic name: TIMOLOL MALEATE
Timoptic	TIMOLOL MALEATE	Bausch & Lomb Incorporated	45ac65b3-19f7-4f33-aebf-cadd3daa4bf1	2022-04-30	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL MALEATE
Timoptic-XE	TIMOLOL MALEATE	Bausch & Lomb Incorporated	a4d03de7-06b7-4cfc-9d1b-616969df209c	2022-03-31	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL MALEATE
Timoptic in Ocudose	TIMOLOL MALEATE	Bausch & Lomb Incorporated	d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf	2022-01-31	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Mylan Pharmaceuticals Inc.	57c62928-63d8-4505-9b9e-c085a3a12c95	2020-07-06	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-189	Timolol Maleate	Timolol	Akorn	ANDA	Current
17478-189	Timolol Maleate	Timolol	Akorn	ANDA	Current
17478-189	Timolol Maleate	Timolol	Akorn, Inc.	ANDA	Current
17478-189	Timolol Maleate	Timolol	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65099	ORIG	2020-10-30